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Development Resource Group

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Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8145
Region : Twin Cities

Seeking a Quality Engineer to initiate medical device quality assurance activities for a major medical device company. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.


Posted: January 21, 2021, 8:07 am
Category : Quality Engineering
Job Type : Contract
Id : 8144
Region : Twin Cities

Seeking a Supplier Development Quality Engineer to be responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection for a major medical device company. This engineer contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.



Posted: January 21, 2021, 7:31 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8143
Region : Twin Cities

Seeking a Manufacturing Process Engineer for the evaluation of production equipment, production support, and process validation for a major medical device company. Additional responsibilities include: troubleshoot manufacturing process and equipment, protocol and report writing, generate and modify manufacturing process documentation. This position will work with cross functional teams as required and develop and implement process improvements for valve production.



Posted: January 21, 2021, 7:21 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8142
Region : Twin Cities

The Senior Product Engineer is responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; and optimizing device production relative to cost constraints. Assumes responsibility for device after transfer into high volume production and usually responsible for entire device manufacturing operations other than wafer fabrication. May assist customer in device usage problems or customer testing of complex devices.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area.
  • Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: January 21, 2021, 6:32 am
Category : Systems Engineer
Job Type : Contract
Id : 8141
Region : Twin Cities

The Senior Systems Engineer performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: January 21, 2021, 6:23 am
Category : Packaging Engineer
Job Type : Contract
Id : 8140
Region : Twin Cities

The Senior Packaging Engineer designs, develops, and tests a wide variety of containers used for the protection, display, and handling of medical device products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: January 20, 2021, 10:25 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8139
Region : Twin Cities

Seeking a Mechanical Engineer that will help develop company products from concept, through design, and in to volume manufacturing. The role will work on mechanisms, actuators, create Test Plans and Reports, create ECOs, and support continuing engineering activities. The role also requires strong opto-mechanical knowledge.

  • Design and analyze mechanical parts.
  • Manage complex product assemblies in Solidworks.
  • Work closely with electrical engineers to develop tightly-integrated, compact electromechanical solutions.
  • Source and collaborate with engineering consultants, industrial designers, contract manufacturers, and parts vendors
  • Take products through engineering analysis and design validation testing phases using skills of both the internal team and outside resources such as test labs and consultants
  • Cooperate with manufacturing organization and outside vendors in creating fixtures manufacturing and testing

Requirements:

  • BS or advanced degree in Mechanical Engineering or related fields
  • Entry Level to 1 year of experience as a Mechanical Engineer
  • Experience in design of precision optical systems required
  • Good CAD skills preferably in Solidworks.
  • Ability to integrate complex ID surfaces.
  • Familiarity with CAE tools with regards to thermal dissipation, stress strain, and impact
  • Experience with design and requirements of medical devices is a plus
  • Knowledge of statistical tolerance analysis
  • Broad knowledge of opto-mechanical components and systems.


Posted: January 20, 2021, 7:46 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 8137
Region : Twin Cities

The Mechanical Design Engineer is responsible for development of the precision alignment equipment that produces sensors. This includes concept design, detail design, testing, documenting, and transferring the design into production.

Core Responsibilities:

  • Mechanical design of precision alignment equipment
  • Design of custom machined and sheet metal parts
  • Design opto-mechanical mounts to provide precise alignment, adjustment, and robustness to meet critical optical performance requirements
  • Selection and integration of precision motion
  • Design for operator ease of use, human factors, and safety
  • Communicate with internal customers to define requirements
  • Collaborate with production on design manufacturability
  • Consult with manufacturing partners on part fabrication
  • Assemble and test final hardware
  • Create product drawings and project documents
  • Transition new designs to production and support existing production

Experience, Education and Competencies Required:

  • 3+ years of experience designing precision processing equipment, inspection equipment, precision equipment, sensors, or electro-mechanical instruments
  • Experience as a mechanical design engineer, designing custom machined and fabricated parts
  • B.S. degree in Mechanical Engineering, or equivalent field
  • Proficient in mechanical CAD (Pro/Engineer preferred) and exposure to CAD data management
  • Experience/knowledge of manufacturing processes especially machining and low volume sheet metal.
  • Experience in a structured development process from requirements definition, to concept design, to detail design, to testing, and implementation into production
  • Experience in, or ability to learn, operating a mill and lathe for part modification and fabrication
  • Must work well in teams with other Engineering disciplines, including Electrical, Optical, Software, and Manufacturing
  • Good interpersonal skills. Good oral and written communications.

Experience, Education and Competencies Preferred:

  • Mechanical design of precision sensors
  • Design of opto-mechanical assemblies a plus


Posted: January 20, 2021, 7:23 am
Category : Reliability Engineer
Job Type : Contract
Id : 8138
Region : Twin Cities

The Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs for a major medical device company.

  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: January 20, 2021, 7:17 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8136
Region : Twin Cities

The Manufacturing Engineer works closely with Operations, Quality and the Laboratory to improve existing manufacturing processes that produce products of the highest quality and reliability for a major medical device company. Seeking candidates who will meet or exceed our customers’ expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.

A Day in the life:

  • Support the TYRX production line
  • Work effectively in highly cross-functional project teams and work independently to accomplish project goals.
  • Follow established procedures to perform and participate in improvement initiatives for detailed, accurate, and compliant engineering documentation
  • Navigate through current state, trouble shoot; determine root cause and actions to address issues.
  • Partner with Quality, Laboratory and Operations and utilize DRM /COS/ lean principles to create technical solutions for product assembly that are consistent with organization objectives.

Must Have - Minimum Requirements:

  • Bachelor of Science in Engineering and 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
  • Minimum of 1 years’ experience in operations/process engineering
  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
  • Experience handling multiple tasks concurrently
  • Excellent data analysis skills and proficient in the use of statistical tools in problem solving
  • Knowledge of quality systems
  • Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.).

Nice to Have:

  • Experience with Medical Device Regulation
  • Experience in medical product manufacturing / assembly operations
  • Experience interpreting mechanical drawings
  • Equipment and process validation (IQ, OQ, PQ)
  • Experience with CAPAs, root cause analysis
  • Six Sigma DMAIC training


Posted: January 20, 2021, 6:29 am
Category : Electrical Engineer
Job Type : Permanent
Id : 8135
Region : Twin Cities

The Senior Electrical Engineer will be responsible for the design and development of electrical components/devices used in medical products. This position also includes the reviewing and mentoring other engineers and technicians. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

  • Perform feasibility testing and determining performance specifications.
  • Originate and/or review documentation including input requirements, design output, risk analysis, test methods, verification and validation plans/reports, and manufacturing processes.
  • Create prototypes and evaluate design to ensure conformance with engineering specifications.
  • Responsible for assessment of standards as well as agency testing.
  • Evaluate electronic components to ensure availability, performance, and cost requirements are met.
  • Experience working with Quality, Clinical, Marketing, and Production departments.
  • Hire, train and manage employees and their activities to ensure high performance and accountability, collaboration, respect for diversity, and employee job satisfaction.

Qualifications:

  • Bachelor of Science in electrical engineering or related field; advanced degree preferred.
  • Minimum of 5 years’ experience in the medical device industry;
  • Radio Frequency (RF) and/or analog experience desired.
  • Advanced computer skills including experience with schematic capture and board layout (preferably Altium), circuit simulation, and Matlab/Octave.
  • Ability to communicate concepts, ideas and knowledge effectively and clearly to other individuals and teams.
  • Strong analytical and problem-solving skills.
  • Experience with 60601-1 and 60601-1-2 standards as well as certified test labs.
  • Experience with Good Documentation Practices (GDP).
  • Requires 5% travel.


Posted: January 19, 2021, 12:38 pm
Category : Firmware Engineer
Job Type : Permanent
Id : 8134
Region : Wisconsin

Looking for a talented Lead Electrical Firmware Engineer to develop and maintain hardware and firmware for embedded systems. The ideal candidate will have experience in developing hardware and firmware for new products as well as being able to maintain products that have already been released. The candidate should also have experience with digital circuit design. This candidate will be spending 85% of their time writing embedded firmware (C code) and approximately 15% of their time developing and maintaining hardware.

Responsibilities:

  • Design, develop and maintain firmware for 8/16/32 bit microcontroller-based products
  • Troubleshoot and debug issues with firmware.
  • Write and maintain software in Visual Studio
  • Verify hardware works as designed
  • Document features, issues, and operation of firmware
  • Transfer knowledge to others within the company

Required Skills:

  • Minimum of 5 years work experience
  • C, C#
  • IP Networks
  • Digital circuit design
  • Ability to collaborate and communicate with a team
  • Willingness to learn new skills and programming languages

Desired Skills:

  • VB.NET
  • Microchip PIC Microcontrollers
  • Assembly language
  • Linux
  • Bluetooth
  • SIP
  • Analog circuit design
  • PCB topology
  • git
  • Jira/Confluence


Posted: January 19, 2021, 8:10 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8133
Region : Twin Cities

Looking for a Quality Engineer to initiate medical device quality assurance activities for a major medical device company. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.


Posted: January 18, 2021, 7:05 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8132
Region : Twin Cities

Seeking a Quality Engineer that works closely with development/manufacturing/quality engineering to establish and ensure compliance and quality reliability. Ensure quality of products conform to established standards and agency regulations.

Main Responsibilities:

  • Perform reliability engineering and statistical analysis.
  • Proactive in finding quality improvements related to Reliability Engineering
  • Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Work collaboratively with product development and design assurance.
  • Aides in definition of test equipment as required to accomplish quality responsibilities.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Experience/Background:

  • Bachelor’s Degree Engineering or related
  • Must have fundamental knowledge of concepts, practices, and procedures of a particular field of specialization. Credentials of a Certified Quality Engineer are a plus. Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
  • Must possess good communication and analytical skills.
  • Ability to work under deadlines.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong organizational and follow-up skills, as well as attention to detail.


Posted: January 18, 2021, 6:54 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8131
Region : Twin Cities

A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the company’s products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.

Essential Functions:

  • Ensure company’s adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
  • Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
  • Manage new product Design History Files.
  • Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required to accomplish quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports.
  • Perform tests according to various protocol requirements.
  • Lead completion of risk management and risk analysis including FMEA.
  • Devise design verification and design validation plans for products based on performance specifications and risk analysis
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
  • Support completion of in vitro testing including applicable animal studies.
  • Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assist in specifications and testing of sterilization methods.
  • Lead system and product continuous improvement teams.
  • Reviews Engineering Change Orders, as required.
  • Perform other duties and responsibilities as assigned by senior management.


Posted: January 15, 2021, 1:09 pm
Category : Reliability Engineer
Job Type : Contract
Id : 8130
Region : Twin Cities

The Reliability Engineer completes risk analysis studies of new design and processes for a major medical device company.

  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.

Must Have: Minimum Requirements to be considered for this role, please ensure the minimum requirements are evident on your resume.

  • Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.

Nice to Have:

  • Advanced degree in Engineering or Science
  • Proven understanding of reliability engineering principles
  • Strong understanding of and experience in the application of statistics, including experience with Minitab
  • Experience in a highly-regulated industry, preferably implantable medical devices
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
  • Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques.


Posted: January 15, 2021, 11:59 am
Category : R&D Engineer
Job Type : Contract
Id : 8129
Region : Twin Cities

We are seeking a high caliber R&D Engineer to support EU MDR for implant medical devices and delivery systems for a major medical device company.

 

Primary Responsibilities

  • Engineer with work on cardiac occluders and associated delivery system - remediation and continuous improvement activities
  • Perform, summarize and present research to assist the team in meeting project requirements
  • Participate in or lead problem-solving investigations
  • Develop or improve test methods utilizing skill sets including mechanical design, prototyping, problem solving and measurement systems analysis
  • Support materials compliance teams with BOM, identification and verification of patient contacting and invasive component list
  • Updates to DHF, design inputs/outputs and product specification as applicable (from detailed gap assessment)
  • Update design prints as necessary (materials compliance)
  • Support design quality engineers with risk management updates (frequency of occurrence and assessment of risks)
  • Ensure biocompatibility documentation is complete, update as necessary with shared biocompatibility services
  • Execute V&V work including performing, monitoring, and reporting testing (to current standards as applicable)
  • Support inputs for General Safety and Performance Requirements (GSPR).

 

Qualifications

  • Bachelor's degree in Mechanical Engineering, Biomedical, or other related engineering field.
  • 1-3 years of related work experience, primarily in R&D engineering
  • Experience in various aspects of designing and testing medical devices
  • Knowledge and understanding of a variety of engineering disciplines, theories and concepts, to support development of innovative approaches to problem solving
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Demonstrated experience writing test methods, model development and identifying potential issues with designs
  • Ability to work well independently and as a member of a team is essential.

 

Preferred:

  • Advanced degrees in a science and engineering discipline
  • Experience in designing catheter and delivery system and knowledge of manufacturing process
  • Working knowledge of the E.U. medical device regulation a plus
  • Metals experience a plus – stainless steel and nitinol material – including processing and evaluation methods
  • Product testing and test method development
  • Solidworks or other CAD experience

 

Posted: January 15, 2021, 7:20 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8127
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product for a major medical device company. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: January 14, 2021, 6:36 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8126
Region : Twin Cities

The Sr. Manufacturing Engineer will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality for a major medical device company.

Essential Functions:

  • List the significant/essential duties, tasks or responsibilities which employees in this position are actually required to perform.
  • Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions.
  • Provide guidance to other engineers and technicians.
  • Provide technical mentorship to engineers and technicians
  • Conduct Process FMEAs and Process Validations Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts
  • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment
  • Work with Product Development to ensure Design for Manufacturability
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Individual should:

  • Be innovative, resourceful, and work with minimal direction
  • Have excellent organization, problem solving, communication, and team leadership skills
  • Work effectively with cross-functional teams


Posted: January 14, 2021, 6:28 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8125
Region : Twin Cities

A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the company’s products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.

Essential Functions:

  • Ensure company’s adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
  • Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
  • Manage new product Design History Files.
  • Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required to accomplish quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports.
  • Perform tests according to various protocol requirements.
  • Lead completion of risk management and risk analysis including FMEA.
  • Devise design verification and design validation plans for products based on performance specifications and risk analysis
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
  • Support completion of in vitro testing including applicable animal studies.
  • Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assist in specifications and testing of sterilization methods.
  • Lead system and product continuous improvement teams.
  • Reviews Engineering Change Orders, as required.
  • Perform other duties and responsibilities as assigned by senior management.


Posted: January 13, 2021, 12:54 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 8124
Region : Twin Cities

A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the company’s products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.

Essential Functions:

  • Ensure company’s adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
  • Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
  • Manage new product Design History Files.
  • Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required to accomplish quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports.
  • Perform tests according to various protocol requirements.
  • Lead completion of risk management and risk analysis including FMEA.
  • Devise design verification and design validation plans for products based on performance specifications and risk analysis
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
  • Support completion of in vitro testing including applicable animal studies.
  • Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assist in specifications and testing of sterilization methods.
  • Lead system and product continuous improvement teams.
  • Reviews Engineering Change Orders, as required.
  • Perform other duties and responsibilities as assigned by senior management.


Posted: January 13, 2021, 12:44 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 8123
Region : Twin Cities

Seeking a Sr. Manufacturing Engineer to exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company’s environment to take an effective and proactive leadership role in a specific technical manufacturing discipline for a major medical device company.

  • Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
  • Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
  • Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
  • Interaction with peers and mentors on the individual’s projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.
  • Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering. Curriculum trains students in skills required to perform assignments.
  • The individual will typically have had a minimum of 6 years experience in an engineering discipline or advanced education to achieve the level of skill.


Posted: January 13, 2021, 9:17 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8121
Region : Twin Cities

Seeking a Sr. Supplier Quality Engineer to provide support to product development programs for new medical device product for a major medical device company

  • Provide input to and align activities to development project schedule
  • Provide technical expertise during supplier evaluation and selection
  • Lead efforts to prepare external CM/OEM supplier’s product from development through production release
  • Determine the required supplier process development/validation and qualification activities and partner with Supply Chain to communicate requirements to the suppliers
  • Ensure documentation is completed per quality system procedures for supplier process development/validation and product qualification
  • Establish controls (process, product, inspection) at the supplier through receipt at a high volume manufacturing facility based on risk input
  • Provide status updates as required per assigned projects
  • Apply QSR 21CFR Part 820 (Medical Devices) to everyday applications of Supplier Quality Engineering activities
  • Define, establish and implement supplier quality assurance processes for medical device product
  • Lead or participate in product, business process or quality system level improvement initiatives
  • Provide training and coaching to suppliers or Medtronic personnel on Quality System Regulation, ISO and Neuromodulation quality system requirements
  • Participate in internal and supplier audits
  • Travel as required to support assigned projects or other application work requirements. Typically ~ 10 – 15%
  • Requires a technical University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: January 13, 2021, 6:49 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8120
Region : Twin Cities

Seeking a Process Development Engineer to apply engineering principles and ingenuity to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation medical devices.

RESPONSIBILITIES

Process Development:

  • Establish processes based on product and print requirements.
  • Evaluate process and design alternatives based on Design for Manufacturability principles.
  • Production support - Responsible for providing technical support for processes and equipment to manufacturing to ensure high quality and yield
  • Process Optimization – Technical Reports and Test Method Validations
  • Process Validation - Protocol and report writing, as well as execution of IQ/OQ/PQs, and PPQs
  • Root cause analysis and troubleshooting, resolves and/or facilitates the resolution of problems including identifying causes and implementing solutions to prevent re-occurrence.

Project Management:

  • Lead and interact with functional groups (e.g. research and development, quality, manufacturing, supply chain) as necessary to define work breakdown to achieve project goals related to schedule, performance, and cost.
  • Manage program compliance with internal and external standards (e.g. Design Control, Process Validation, and Process Control Plans)
  • Understand work environment issues (e.g. OSHA regulations, etc.)

QUALIFICATIONS

Experience and Education:

  • Bachelor of Science in Engineering
  • 0-4 years engineering experience
  • Ability to work within a team and as an individual contributor in a fast-paced environment.
  • Ability to leverage and/or engage others to accomplish tasks.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
  • Strong organizational skills and attention to detail.
  • Ability to maintain regular and predictable attendance.

Preferred Qualifications:

  • Experience developing manufacturing processes, technologies, and designing for manufacturability of medical devices.
  • Experience with statistical analysis (e.g. Gage R&R, Cpk, SPC, DOE), Minitab preferred.


Posted: January 13, 2021, 6:31 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8119
Region : Twin Cities

Seeking a Development Quality Engineer to participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects for a major medical device company.

Responsibilities:

  • Accountable for generation of PDP design verification test plans/reports for product/system requirements
  • Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports.
  • Completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments.
  • Lead identification of essential outputs and generate Essential Output reports.
  • Accountable for completion of labeling verification activities and labeling verification reports.
  • Work with design engineering in the completion of customer/system/product requirements.
  • Work with design engineering in the completion of product verification and validation.
  • Endure DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps.
  • Complete document change request reviews in a timely and objective manner.
  • Identify and implement effective process control systems to support the development.
  • Qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
  • Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
  • Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements.
  • Additional duties may be identified by functional management based on the current project/business objectives.

Education/Experience:

  • Bachelor level degree in an Engineering Discipline or other technical field experience plus 2-5 years experience.


Posted: January 12, 2021, 8:24 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8118
Region : Twin Cities

A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system for a major medical device company.

Position Responsibilities:

  • Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs. Lead on-time completion of Quality Assurance (QA) engineering deliverables.
  • Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
  • Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.
  • Develop and lead training for QA systems. Influence and guide other team members with product review and analysis for QA activities.
  • Maintain databases and record storage for QA systems. Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
  • Lead meetings and communications for QA system information, concerns, and updates. Lead and mentor others with QA data analysis, trending, and reporting.
  • High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
  • Track and proactively identify concerns manufacturing related complaints in alignment with Company goals.
  • Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues.
  • Seeks out information independently and able mentor/lead other members of the organization on QA practices. Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables.
  • Proficient as lead representative for presenting QA System to internal and external auditors.
  • Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
  • As appropriate, leads in the completion of risk assessment, as related to QA systems.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.
  • Operates a motor vehicle for trips to various Company sites and outside vendor, field, and customer locations; and to commute to various airports for airline.
  • Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

Position Requirements:

  • Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
  • 5+ years technical experience
  • Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies
  • Detailed knowledge of FDA, GMP, and ISO 13485
  • Solid communication and interpersonal skills
  • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Prior medical device experience preferred
  • ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 10%, including internationally.
  • Ability to maintain regular and predictable attendance.


Posted: January 11, 2021, 3:17 pm
Category : R&D Engineer
Job Type : Contract
Id : 8117
Region : Twin Cities

Seeking an R&D Engineer to be responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive).

 

Position Responsibilities:

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
  • Conducts feasibility studies to verify capability and functionality.
  • Develops new concepts from initial design to market release.
  • Directs support personnel and coordinates project activities.
  • Write and submit intellectual property (patents).
  • Maintains detailed documentation throughout all phases of research and development.
  • Investigates and evaluates existing technologies.
  • Reviews or coordinates vendor activities to support development.
  • Write and submit professional articles for technical journals.
  • Research various cost-effective, alternative approaches to current processes.

 

Experience:

  • Bachelor's degree and 0-6 years of related work experience with a complete understanding of specified functional area

 

Posted: January 11, 2021, 2:53 pm
Category : Quality Engineering
Job Type : Contract
Id : 8113
Region : Twin Cities

Seeking a Product Performance Engineer to perform failure analysis on explanted long term biomedical implant product. Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical techniques to identify route cause failure mechanisms.

Must be able to meet deadlines on multiple assignments and be able to operate in a diverse cross-functional team environment and proactive in finding quality improvements related to Failure Analysis.

RESPONSIBILITIES:

  • Required to create/ review/ edit/ update Quality and Technical Documents including, but not limited to: SOPs, work/testing instructions, customer letters, responses to regulatory inquiries, post market surveillance plans
  • Independently gather resources and information needed to complete projects
  • Performs other related duties and responsibilities, on occasion, as assigned.
  • May serve as lead and assign work to less experienced personnel and serves as a mentor when assisting less experienced lab staff in solving more complex problems.
  • Works cross functionally and collaboratively with Product Development, Engineering, Manufacturing, and Product Surveillance.

EDUCATION AND EXPERIENCE YOU’LL BRING:

  • Minimum of Bachelors’ Degree from an accredited University; Engineering/Biomedical Engineering preferred
  • 1-3 yrs of Engineering Experience or experience in a regulated industry (Pharma/Medical Device/Biotech)
  • Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees.
  • A documented record of delivering reliability engineering information which adds value to management’s decision making process is required. Personal computer skills including spreadsheet, word processing database management, and specialized applications.
  • Preferred
  • General knowledge of Quality/Regulatory requirements in a medical device/ pharma/ biotech industry
  • General knowledge of complaint handling and post market surveillance regulatory requirements


Posted: January 8, 2021, 9:41 am
Category : R&D Engineer
Job Type : Contract
Id : 8112
Region : Twin Cities

Seeking an R&RD Engineer with 1-5 years of related work experience supporting MDR remediation activities, specifically related to R&D tasks. Examples of tasks include: Design Verification Testing, Product Requirement development, Test Method Development/Validation, drawing & print revision and release, and managing engineering change orders.

Responsibilities:

  • Responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive).
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Provides R&D support for MDR submission initiatives.
  • Provides R&D support for market-released cardiovascular catheters and introducers.
  • Conducts feasibility studies to verify capability and functionality to support investigations and/or design changes.
  • Develops solutions to improve product function and manufacturability.
  • Directs support personnel and coordinates project activities.
  • Write and submit Engineering Change orders.
  • Maintains detailed documentation throughout all phases of development.
  • Investigates and evaluates design changes, manufacturing changes, NCMRs and/or customer complaints.
  • Reviews or coordinates vendor activities to support development.
  • Research various cost-effective, alternative approaches to current designs and processes.

Education:

  • Bachelor's degree in Mechanical, Biomedical or Electrical Engineering or an equivalent combination of education and work experience


Posted: January 7, 2021, 12:09 pm
Category : R&D Engineer
Job Type : Contract
Id : 8111
Region : Twin Cities

Seeking a Sustaining R&D Engineer with 3+ years of related work experience to provide R&D support for market-released cardiovascular catheters.

Prior medical device engineering experience in R&D preferred

Bachelor's degree in Mechanical, Biomedical or Electrical Engineering or an equivalent combination of education and work experience

Responsibilities include:

  • Provides R&D support for market-released cardiovascular catheters.
  • Conducts feasibility studies to verify capability and functionality to support investigations and/or design changes.
  • Develops solutions to improve product function and manufacturability.
  • Directs support personnel and coordinates project activities.
  • Write and submit Engineering Change orders.
  • Maintains detailed documentation throughout all phases of development.
  • Investigates and evaluates design changes, manufacturing changes, NCMRs, CAPAs and/or customer complaints.
  • Reviews or coordinates vendor activities to support development.
  • Research various cost-effective, alternative approaches to current designs and processes.


Posted: January 7, 2021, 12:04 pm
Category : R&D Engineer
Job Type : Contract
Id : 8110
Region : Twin Cities

Seeking a R&D Engineer responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive). Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.Conducts feasibility studies to verify capability and functionality.Develops new concepts from initial design to market release.Directs support personnel and coordinates project activities.Write and submit intellectual property (patents).Maintains detailed documentation throughout all phases of research and development.Investigates and evaluates existing technologies.Reviews or coordinates vendor activities to support development.Write and submit professional articles for technical journals.Research various cost-effective, alternative approaches to current processes.

Posted: January 7, 2021, 7:46 am
Category : R&D Engineer
Job Type : Contract
Id : 8109
Region : Twin Cities

Seeking a R&D Engineer responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive). Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.Conducts feasibility studies to verify capability and functionality.Develops new concepts from initial design to market release.Directs support personnel and coordinates project activities.Write and submit intellectual property (patents).Maintains detailed documentation throughout all phases of research and development.Investigates and evaluates existing technologies.Reviews or coordinates vendor activities to support development.Write and submit professional articles for technical journals.Research various cost-effective, alternative approaches to current processes.

Posted: January 7, 2021, 7:45 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8108
Region : Twin Cities

The Mechanical Design Engineer researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy for a major medical device company. Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs. May be responsible for the transfer from R&D to manufacturing.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: January 6, 2021, 6:15 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8107
Region : Twin Cities


The Supplier Quality Engineer ensures that suppliers deliver quality parts, materials, and services for a major medical device company. This engineer qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess

 

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

 

DIFFERENTIATING FACTORS:

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: January 4, 2021, 12:09 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 8106
Region : Twin Cities

Seeking a Production Engineer to design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality for a major medical device company.

Main Responsibilities:

  • Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions.
  • Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts.
  • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment
  • Work with Product Development to ensure Design for Manufacturability
  • Conduct Process Validations and participate in process FMEAs

Individual Should:

  • Be innovative, resourceful, and work with minimal direction; have excellent organization, problem solving, communication, and team leadership skills; work effectively with cross-functional teams
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Position Requirements:

  • Bachelors Degree (± 16 years): Mechanical, Chemical or any engineering or technical degree.
  • Minimum 5 years of Manufacturing engineering experience
  • Medical device experience required
  • Strong analytical, problem solving and project management skills.
  • Demonstrated leadership capability in team settings. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.


Posted: January 4, 2021, 9:45 am
Category : Systems Engineer
Job Type : Contract
Id : 8105
Region : Twin Cities

Seeking a Principal Systems Product Engineer to perform product and device-oriented cybersecurity-related activities ranging from incident response to vulnerability assessments to mitigation implementation for a major medical device company.

Responsibilities Include:

  • Conduct product risk assessments in conjunction with product R&D teams and develop and recommend specific security controls for product/system wide security needs.
  • Participate in the creation and testing of product security-related requirements and processes.
  • Evaluate security risks on programs across the entire development lifecycle, including market-released product.
  • Ownership of security-related deliverables for regulatory bodies, ensuring compliance with key standards / guidance documents, and represent SI to those regulatory bodies
  • Contribute to Company’s understanding of current industry best practices and how they can be applied to SI Products.
  • Work under minimal consultative direction toward long range program goals and objectives.
  • Develops technical ideas and guides their development into final product.
  • Maintain a high level of technical knowledge on security.
  • Implementation of the Security Development Lifecycle across projects
  • Consistent implementation of the Quality System across projects
  • Create relationships and contracts with external vendors for security products, consultation, or other services

Qualifications – Must Have:

  • Bachelor’s degree required
  • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice to Have:

  • 3+ years in critical Systems Security Engineering related roles or
  • 5+ years of experience with a Master’s Degree in a technical/engineering discipline including 3+ years in critical Systems Security Engineering related role
  • Broad experience with information and systems security.
  • Demonstrated leadership, team work skills and project management, including ability to create and track to broader goals and vision.
  • Demonstrated experience with Risk Management and Systems Engineering processes.
  • Demonstrated ability to develop and grow productive, trusting and open relationships with a wide variety of constituencies.
  • Demonstrated ability to lead and communicate across organizations and geographies in a crisp manner.
  • Demonstrated strong analytical, problem solving skills.
  • Proven record of working independently and understanding program goals
  • Experience in Healthcare industry or other heavily regulated industry.
  • In-depth understanding of system development lifecycle methodologies.
  • Design and implementation experience with security for:
  • Embedded software & systems
  • Capital equipment in a hospital setting
  • Mobile applications, OS, cloud systems
  • IoT
  • Experience with Clinical IT and Clinical IT Security stakeholders
  • In-depth medical device systems knowledge and experience
  • Prior security design experience in critical industries such as DOD, DOE, NSA
  • Specialized knowledge desired:
  • Ethical hacking (certification preferred)
  • Embedded devices
  • Research and Development
  • Relevant engineering processes and skills Security technologies and approaches
  • Medical device technology
  • Wireless communication systems


Posted: December 23, 2020, 6:19 am
Category : Software Engineer
Job Type : Contract
Id : 8103
Region : Twin Cities

Seeking a Sr. Systems Security Architect to be involved in Security By Design for a new continuous glucose monitor product development program for a major medical device company.

 

A day in the life:

  • Develop security plan for next generation disposable sensor, electrical and firmware.
  • Work with systems to author testable cybersecurity requirements in the next generation CGM security design.
  • Author a test plan that covers all next generation CGM security requirements.
  • Develop a penetration test plan for next generation CGM electrical and firmware.
  • Present security and penetration test plans to Company Diabetes security council for review and approval.
  • Coordinate security plans with mobile software security architect and cloud software security architect.
  • Perform a risk analysis on security vulnerabilities as they are discovered and coordinate any risk mitigation activities and reports.
  • Stay up to date with security threats and best practices, and understand their impact on different system components.
  • Coordinate test creation, execution, and documentation with external contractors' test teams.
  • Coordinate with internal test team to automate security testing as part of the existing test framework.

 

Required Knowledge and Experience:

  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  • May have practical knowledge of project management.
  • Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

 



Posted: December 18, 2020, 6:14 am
Category : Mechanical Designer
Job Type : Contract
Id : 8099
Region : Twin Cities

Seeking a Mechanical Design Engineer to work within the Released Product Engineering design team. Responsible for leading mechanical design engineering projects for stimulator leads, neurostimulators and accessories.

Position Responsibilities

  • Mechanical Design Engineer for Neuromodulation Implantable Neuro Systems. These systems are used to treat movement, gastro-uro and pain disorders.
  • Lead and support design changes that are primarily mechanical in nature with the engineer cognizant of non-mechanical materials and electrical interfaces.
  • Balance deliverables on multiple simultaneous project assignments with minimal oversight.
  • Drive projects to closure within specified milestones while being flexible on project assignments.
  • Evaluate existing fielded products and lead design changes that improve manufacturability, quality, reliability, and/or reduce cost.
  • Demonstrate effective cross functional teaming by working with Manufacturing, Supply Chain, Quality, Reliability, and Regulatory Functions to qualify and implement design changes.
  • Responsible to lead and perform detailed design analysis on critical design elements, participate, support or potentially lead corrective action teams to resolve quality issues (per PIE, FI, NC and CAPA processes). Ensure compliance to quality management system for assigned tasks.
  • Effectively lead project elements in a cross functional teaming environment.

Basic Qualifications

  • B.S. in Mechanical Engineering or other related technical/engineering discipline with 2+ years of job-related experience; or MS degree with 0 years of job-related experience in the medical device industry.
  • Direct knowledge and experience working with Company subsystems related to DBS, SCS and/or PH therapies.
  • Experience working with Company Configuration Control Boards, Functional Review Boards and Day to Day (D2D) processes.
  • Demonstrated excellent written, verbal, and presentation/communication skills.
  • Proven ability to work independently with minimal oversight and complete tasks within scheduled milestones.

Desired/Preferred Qualifications:

  • Demonstrated excellent project management skills and high level of computer competency.
  • Knowledge and experience working with DRM/DFSS/Six Sigma Green Belt or Black Belt is a plus
  • Experience using engineering statistical tools/methods such as Minitab, Design of Experiments (DOE) methodologies, Hypothesis testing, capability analysis, measurement systems analysis and other six sigma methods as appropriate


Posted: December 10, 2020, 7:07 am
Category : Project Manager
Job Type : Contract
Id : 8096
Region : Twin Cities

The Engineering Project Manager plans, directs and implements all aspects of the company's design and development of new medical device products or software systems. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes or products. Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended. Monitors documentation maintenance throughout all phases of research and development. Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

  • Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms.
  • Organizational Impact: Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. May have budget or P&L accountability for a department, function or geography. Strive for continuous improvement and consistency in deliverables.
  • Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
  • Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties. May interact on issues that have externally shared objectives.
  • Leadership and Talent Management: Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments. Authorizes hiring, firing, promotion and reward within own area.
  • Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Requires a University Degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.


Posted: December 8, 2020, 1:46 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 8095
Region : Twin Cities

As a Sr. Human Factors Design Engineer, you will apply your knowledge of human performance and human factors techniques to the ideation, design, and development of products offered by the Renal Care business unit for a major medical device company. You will need a solid understanding of the theories, principles, and data associated with human performance capabilities and limitations (perceptual, cognitive, motor, bio-mechanical, and anthropometric) and the ability to apply this knowledge to the design, definition, evaluation, and use of products in the renal care space.

This engineer will provide Human Factors support across the product lifecycle including customer and user needs identification, development of user and workplace profiles and usage scenarios, task analysis, requirements specification, generation of hardware and software design concepts in collaboration with the engineering teams, user interface design, usability testing, and use error analysis.

Performance of these within the constraints of a complex regulated environment; and in partnership with engineering (Software, Firmware, Hardware, Mechanical, and Systems), research, technology, product planning, clinical, regulatory, and marketing groups.

Position Responsibilities

  • Collaborate with the human factors project leads as well as the cross-functional teams to understand product evaluation needs for formative and summative studies
  • Apply appropriate human factors methods and analysis techniques to execute formative and summative studies and describe additional design needs based on analysis
  • Support the full range of human factors needs for product development
  • Must Have: Minimum Requirements
  • Master’s degree in Human Factors, Engineering Psychology, Cognitive/Experimental Psychology, Kinesiology, or other relevant degree with 2+ years experience
  • Knowledge in human performance theories, design guidelines and principles, and data repositories associated with human capabilities and limitations
  • Knowledge and experience with human factors evaluation methods and analysis techniques to understand the user’s performance with a system or product (e.g., task analysis, cognitive walkthrough, experimental research and/or usability test methods, data analysis techniques)
  • Knowledge in usability standards for medical device development (e.g., IEC 62366-1:2015, IEC 60601-1-6; IEC 60601-1-11; ANSI/AAMI/HE75; FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices)
  • Experience conducting formative and/or summative studies for medical device product development
  • Being willing to travel (when required)

Nice to Have:

  • Experience performing use error analysis or risk analysis for medical devices
  • Previous experience in renal care product development and/or knowledge of dialysis treatment
  • Experience collaborating and communicating with a distributed global team


Posted: December 8, 2020, 11:26 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8092
Region : Twin Cities

The Materials Engineer analyzes, researches, designs and develops materials and their related fabrication and application processes to develop and optimize materials for use in engineering design of and/or application in structures, systems and subsystems. Applies principles of chemistry, physics, and material behavior to develop metallic, nonmetallic and composite material and processing specifications, fabrication and assembly processes. Develops, analyzes and applies material properties and design allowables, processing processes and quality engineering specifications. Material analyses may include failure analysis of components, systems and subsystems, life predictions, and definition and requirement specifications. May review and approve subcontractor material processing procedures.

The ideal candidate is well versed in materials analysis, both polymers and metals (Chemical Engineer, Chemistry, Materials Science degrees or experience). The primary responsibility will be to support an alternative sterilization assessment where materials samples are being exposed to various sterilization chemistries. Metals, polymers, adhesive joints, welds, and products are being analyzed for evidence of any degradation reactions that were initiated by the new sterilization chemistry. Analytical techniques include, microscopy (optical and SEM), size exclusion chromatography, liquid chromatography mass spectrometry, electron spin resonance. Previous experience is desired but not a requirement. Looking for a highly motivated candidate willing to learn.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: December 8, 2020, 7:29 am
Category : Quality Engineering
Job Type : Contract
Id : 8091
Region : Twin Cities

We are seeking an experienced, high caliber Development Quality Engineer II to assure that new or modified products conform to quality standards and establish compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Lead on-time completion of Design Control Deliverables
  • Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for generation of PDP design verification test plans/reports for product/system requirements
  • Lead or support Risk Management activities from product Concept through Commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA’s and Cybersecurity risk assessments
  • Lead identification of essential outputs and generate Essential Output reports
  • Accountable for completion of labeling verification activities and labeling verification reports
  • Work with design engineering in the completion of customer/system/product requirements
  • Work with design engineering in the completion of product verification and validation
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Complete Document Change Request Reviews in a timely and objective manner
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Additional duties may be identified by functional management based on the current project/business objectives
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Minimum Requirements:

  • Bachelor level degree in Engineering or other Technical Field
  • 2-5 years’ Medical Device engineering experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485
  • Experience supporting product design and development
  • Solid communication and interpersonal skills
  • Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail

Preferred qualifications and education:

  • Prior Development Quality engineering experience
  • Experience working in a broader enterprise/cross-division business unit model



Posted: December 8, 2020, 6:55 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8090
Region : Twin Cities

Seeking a Senior Manufacturing Engineer to exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company’s environment to take an effective and proactive leadership role in a specific technical manufacturing discipline. This position will set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements. Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required. Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components. Interaction with peers and mentors on the individual’s projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.

Requirements:

  • Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering.
  • Minimum of 6 years of experience in an engineering discipline or advanced education.


Posted: December 8, 2020, 6:45 am
Category : Quality Engineering
Job Type : Permanent
Id : 8085
Region : Twin Cities

We are looking for a Quality Engineer who will play an integral role to improve customer satisfaction, drive supplier quality improvements, and support continuous improvement objectives throughout the organization. This position will support Quality function in promoting quality assurance and in interfacing with key areas of the company, its customers and suppliers on critical quality issues. The Quality Engineer will also work cross-functionally to maintain the ISO quality management system to ensure compliance with all internal and external quality requirements.

 

Core Responsibilities:

  • Monitor customer and supplier quality issues associated with defined product families; maintain quality databases; determine failure trends, initiate corrective actions and support teams to address systemic issues using data driven approach and suitable problem solving techniques.
  • Support 8D process in containment actions, root cause investigations, corrective/preventative actions, verify or validate corrective actions and monitoring issue recurrences.
  • Proactively initiate CIP projects to identify and improve product or process capability, reliability, and quality.
  • Track customer complaints, coordinate diagnosis of customer returned units and analyses of complex failures between internal teams, suppliers and external test labs.
  • Analyze, develop and maintain meaningful quality metrics and generate quality statistics reports on a regular basis to bring customer and supplier quality visibility to Quality Management.
  • Generate failure analysis reports, response packages for external reporting to address customers' quality concerns.
  • Monitor incoming parts and non-conforming material/outputs data; maintain supplier quality metrics and accordingly engage suppliers for corrective actions/improvements.
  • Monitor product build quality; generate quality notices to correct build anomalies observed by the inspection team/customer.
  • Perform internal audits; provide support in audit preparations and participate in ISO 9001 and customer audits.
  • Apply and maintain quality procedures, work instructions and records in accordance with ISO 9001:2015 standard and customer requirements.
  • Monitor, measure and analyze key performance indicators on companywide processes by gathering relevant data and producing statistical reports for visibility to Quality Management.

 

Experience, Education and Competencies Required:

  • Bachelor's degree in Engineering, Science or a related engineering field.
  • Minimum of 3 years' experience in Quality or Manufacturing or Engineering or combined.
  • Experienced and competent in the methods and application of tools such as, Pareto, Corrective and Preventive Action (CAPA), 8D, 5-Why, Fishbone analysis and FMEA.
  • Proficient in interpreting, generating and maintaining quality metrics (failure rates, DPU, PPM), failure analysis and reporting.
  • Must be detail oriented, creative and perceptive with the ability to multi-task.
  • Ability to work in a collaborative and cross-functional team environment.
  • Must be flexible and willing to execute tasks as directed by Quality Management.

 

Preferred Experience:

  • Experience in statistical applications tools such as Minitab, Excel, or related SPC tools/software.
  • Experience with ISO quality management system.


Posted: December 2, 2020, 1:05 pm
Category : Software Engineer
Job Type : Contract
Id : 8083
Region : Twin Cities

Seeking a Software Engineer to join a dynamic and motivated team in Electro Physiology (EP), developing medical products that set the bar for clinical excellence and efficient workflow. Products provide cutting edge, advanced software to enable 3D cardiac models which help in diagnosing and treating cardiac disease. As a member of the software development team you will help take these products to the next level and reduce cost, improve quality, increase access.

Essential Responsibilities:

  • Have familiarity with all aspects of Software Development Life Cycle and methodologies
  • Write well-designed, testable code
  • Develop Machine learning capabilities for recognizing and analyzing cardiac images
  • Work closely with cross-functional teams in Systems and hardware/firmware to develop optimal solutions combining software and embedded software on FPGA’s
  • Integrate software components into functional software system
  • Develop graphical user interface components
  • Develop manual and automated tests for software verification as needed
  • Develop and maintain documentation to identify design, requirements and solutions
  • Communicate effectively both within immediate team and across the program and business leadership team

Qualifications/Requirements:

  • Bachelor’s Degree in Engineering or Computer Science or related field
  • 3+ years hands on experience with development in C++ and Qt/QML
  • Desired Characteristics
  • Master’s Degree in Engineering or Computer Science ore related field
  • Strong understanding of the hardware/software interface
  • Experience working in a Linux environment
  • Experience working in a regulated environment (preferably medical)
  • Strong oral and written communication skills
  • Strong interpersonal skills
  • Software development tool experience such as Perforce, Jira, Jenkins


Posted: December 1, 2020, 11:06 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8081
Region : Twin Cities

The Senior Materials Engineer analyzes, researches, designs and develops materials and their related fabrication and application processes to develop and optimize materials for use in engineering design of and/or application in structures, systems and subsystems for a major Medical Device company. This engineer applies principles of chemistry, physics, and material behavior to develop metallic, nonmetallic and composite material and processing specifications, fabrication and assembly processes. Develops, analyzes and applies material properties and design allowables, processing processes and quality engineering specifications. Material analyses may include failure analysis of components, systems and subsystems, life predictions, and definition and requirement specifications. May review and approve subcontractor material processing procedures.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: November 25, 2020, 10:34 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8068
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for testing products. Collaborates with R&D engineering and manufacturing functions to ensure requirements are met for Failure Analysis testing. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Equipment Qualifications, Test Method Validations and Project lead on New Product introduction as it relates to Repair and Return Product Analysis. Designs or specifies inspection and testing mechanisms and equipment; redline and release new work instructions of (SOP). Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS:

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
    Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: November 11, 2020, 2:59 pm
Category : R&D Engineer
Job Type : Contract
Id : 8067
Region : Twin Cities

Seeking an R&D Engineer to be responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive). Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Responsibilities include:

  • Provides R&D support for market-released transseptal needle.
  • Conducts feasibility studies to verify capability and product functionality with regards to device leak resistance.
  • Develops solutions to improve product function and manufacturability with regards to device leak resistance.
  • Develop and/or possess knowledge of machining techniques, and valves per ISO 80369
  • Directs support personnel and coordinates project activities.
  • Write and submit Engineering Change orders.
  • Maintains detailed documentation throughout all phases of development.
  • Reviews or coordinates vendor activities to support development.

Position Requirements:

  • Bachelor's degree in Mechanical, Manufacturing or Biomedical Engineering or an equivalent combination of education and work experience
  • 3+ years of related work experience with a complete understanding of specified functional area
  • Prior engineering experience in R&D preferred


Posted: November 10, 2020, 2:14 pm
Category : R&D Engineer
Job Type : Contract
Id : 8064
Region : Twin Cities

Seeking a talented R&D Engineer, Human Factors Engineer to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of Electrophysiology Systems, this is part of the Atrial Fibrillation business unit.

Position Responsibilities:

  • Apply knowledge of human factors principles (human performance and limitations – perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to cardiac electrophysiology systems product development.
  • Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization.
  • Deliverables include, but are not limited to: Usability engineering files, Task analyses, and Usability risk analyses
  • Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs.
  • Develop collaborative working relationships with other functions across the organization, including but not limited to the following: Work with regulatory affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies
  • Work with design quality to ensure that the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
  • Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering.
  • Represent in meetings with regulatory agencies, at human factors professional meetings and conferences, and as a member of standards committees.

Position Requirements:

  • Proven ability to work with multidisciplinary teams that may include other human factors experts.
  • Proven ability to interface with customers in a highly professional manner.
  • Proven ability to apply user-centered design and human factors/usability engineering principles to product research, development and design.
  • Experience in medical device development.
  • Ability to quickly assimilate advanced domain knowledge.
  • Excellent verbal and written communication and presentation skills
  • Education: M.S. degree in Human Factors Engineering or Cognitive Psychology or M.S. degree in Biomedical Engineering with extensive human factors coursework.
  • Minimum of 5 years of relevant human factors/usability engineering experience in hardware-software systems product development; prefer 10+ years of experience



Posted: November 9, 2020, 9:55 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8063
Region : Twin Cities

The Principal Biomedical Engineer designs, develops and provides safety testing, repair, and maintenance of biomedical equipment for a major medical device company. This engineer ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS:

  • Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
  • Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.
  • Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
  • Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decision making.
  • Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
  • Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: November 9, 2020, 9:22 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8054
Region : Twin Cities

This is a Principal Mechanical Engineering position within the R & D product development area. This person will provide mechanical engineering leadership with developing and commercializing a medical device system. This position will lead and be responsible for the mechanical design, development and test for mechanical device components of a neuromodulation system for treatment of chronic migraines, and will provide task scoping, design cost analysis and project planning to the R&D product development area. This person will work with other engineers and technicians to achieve project milestones and product functionality.

  • Plays primary technical role in mechanical design, test, and documentation to meet compliance and product requirements and satisfy customer needs of a medical device system.
  • Works independently as well as with the functional and project teams to develop technical solutions to complex problems that require ingenuity and creativity.
  • Leads troubleshooting and problem-solving efforts related to mechanical design of active implantable and / or external instruments and associated systems. Supports and communicates decisions through thorough engineering practices and data analysis.
  • Creates and communicates design/test plans, tasks, deliverables and status. Manages time and resources to meet committed schedule milestones.
  • Participates or leads in the definition of product /design requirements, mechanical development, design and implementation of mechanical components and the documentation and release of designs.
  • Responsible for generating or improving mechanical designs that are optimized for production, reliability, regulatory compliance, and cost.
  • Follows documented design processes to meet regulatory and company requirements. Responsibilities include generating engineering documentation for a design control process in a regulated environment.
  • Interfaces with vendors, manufacturing, and other internal groups, and provides work direction to contractors, lab personnel and other technical staff while executing design tasks. Mentors and provides technical assistance as required.
  • Create and release engineering drawings, written procedures, and Bill of Materials
  • Work with suppliers to ensure components meet design requirements & diagnose design problems.
  • Performs design transfer from R&D to manufacturing

Required:

  • Bachelor's degree in Mechanical Engineering, Physical Science, or related
  • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Preferred:

  • MS in Mechanical Engineering with a minimum of 7 years engineering experience
  • Knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
  • Knowledge of standards and directives such as IEC 60601, IEC 61010, UL, ANSI and ASTM, RoHS/EE/WEEE
  • Prior relevant technical lead or team lead roles
  • Task planning, sub-team management and leadership skills and experience
  • Experience developing Class II and Class III medical devices
  • Experience 3D modeling software, i.e. SolidWorks and/or ProEngineer
  • Experience designing and developing mechanical assemblies
  • Geometric Dimensioning and Tolerance (GD&T) practices
  • Ability to manage multiple tasks and projects
  • Experience creating technical, written content
  • Demonstrated data analysis skills
  • Ability to interpret technical drawings and creating Bill of Materials
  • Demonstrated written and verbal communication skills
  • Experience designing and developing electromechanical assemblies
  • Strong understanding of mechanical engineering principles and methodologies
  • Experience with the design and manufacture of medical devices
  • Experience in product design and development in an R&D environment
  • Formal training in DMAIC or Six Sigma with Greenbelt or Blackbelt
  • Ability to use structural finite elements software such as Cosmos or Ansys
  • Experience in plastic part design and injection molding
  • Experience in developing verification and validation protocols
  • Working knowledge of Microsoft Office tools
  • Communication, presentation, technical writing, and organizational skills
  • Familiarity with systems, electrical, and software engineering disciplines
  • Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, risk management
  • Experience using statistical analysis software to prepare test data for regulatory review (e.g. Minitab, MedStat)
  • Experience incorporating design for manufacture techniques to improve yields
  • Experience with component qualifications, including using external manufacturers to build custom components
  • Experience managing component inventories both internal and at external manufacturers
  • Experience in management of test equipment calibration


Posted: November 3, 2020, 8:37 am
Category : Test Engr - Technical
Job Type : Contract
Id : 8053
Region : Twin Cities

Verification and Validation Engineering position within the R&D product development area. This person will provide verification and validation engineering with developing and commercializing a medical device system. This position will be responsible for the subsystem level verification, system level integration, system verification and validation and for embedded electronic device components of a neuromodulation system for treatment of chronic migraines, and will provide task scoping, design cost analysis and project planning to the R&D product development area. This person will work with other engineers and technicians to achieve project milestones and product functionality.

  • Plays primary technical role in verification and validation testing and documentation to meet compliance and product requirements and satisfy customer needs of a medical device system.
  • Works independently as well as with the functional and project teams to develop technical solutions to complex problems that require ingenuity and creativity.
  • Develop comprehensive integration test plans including definition of objectives, entry and exit criteria, required progressions or phases, performance metrics, and tools.
  • Utilize knowledge of testing techniques and methodologies to define test strategies to manage and perform integration testing
  • Ensure proper configuration of the system is produced and traceability of the tests to requirements and objectives.
  • Ability to identify, coordinate and schedule testing resources to accomplish project milestones.
  • Analyze information and test data and help influence resolutions/solutions.
  • Responsible for identifying, reporting and tracking defects, and for creating metrics to track progress.
  • Provide effective communication across all teams.
  • Apply technical engineering to support the design of systems, products, and their features with a strong customer focus.
  • Drive subsystem and product characterization testing and verification testing
  • Perform end to end system level verification testing and lead validation testing to demonstrate coverage of user needs and intended uses
  • Perform technical planning for system integration and verification, evaluates alternatives including new technologies and methods, feasibility as well as identifying technical and project risks.
  • Develop a strong and collaborative team environment, coach and promote a culture around integration that crosses all functional teams.
  • Leads troubleshooting and problem-solving efforts related to active implantable and / or external instruments and associated systems. Supports and communicates decisions through thorough engineering practices and data analysis.
  • Creates and communicates design/test plans, tasks, deliverables, and status. Manages time and resources to meet committed schedule milestones.
  • Follows documented design processes to meet regulatory and company requirements. Responsibilities include generating engineering documentation for a design control process in a regulated environment.

Required:

  • Bachelor’s degree in Engineering, Physical Science, Computer Science or related discipline
  • Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience

Preferred:

  • MS in Engineering or with a minimum of 7 years engineering experience
  • Knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971 standards
  • Knowledge of standards and directives such as IEC 60601, IEC 61010, UL, ANSI, ASTM, and RoHS/EE/WEEE
  • Prior relevant technical lead or team lead roles
  • Task planning, sub-team management and leadership skills and experience
  • Experience developing Class II and Class III medical devices
  • Experience with key technologies such as inductive telemetry, wireless and wired charging, thermal modeling, BLE, boost power supply design in a neuromodulation system
  • Knowledge of system and software engineering architecture principles, concepts, and best practices
  • Performs technical planning, system integration, verification, and validation, evaluates alternatives including cost and risk, supportability, and analyses for total systems.
  • Analyses are performed at all levels of total system product to include concept, design, fabrication, test, installation, operation, maintenance, and disposal.
  • Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
  • Excellent written and communication skills
  • Experience with development in a regulated industry such as medical device, defense, or automotive
  • Experience in the evaluation of electrical stimulation waveforms for neuromodulation therapy
  • Experience evaluating and reporting key design parameter performance and providing input for design improvement using common test equipment: oscilloscopes, signal generators, multimeter, current meters, LCR meters, power supplies
  • Experience in developing verification and validation protocols
  • Working knowledge of Microsoft Office tools
  • Familiarity with systems, electrical, mechanical and software engineering disciplines
  • Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, risk management
  • Experience using statistical analysis software to prepare test data for regulatory review (e.g. Minitab, MedStat)
  • Experience in management of test equipment calibration


Posted: November 3, 2020, 8:08 am
Category : Electrical Engineer
Job Type : Contract
Id : 8052
Region : Twin Cities

This is a Principal Electrical Engineering position within the R&D product development area. This person will provide electrical engineering leadership with developing and commercializing a medical device system. This position will lead and be responsible for the electrical design, development and test for embedded electronic device components of a neuromodulation system for treatment of chronic migraines, and will provide task scoping, design cost analysis and project planning to the R&D product development area. This person will work with other engineers and technicians to achieve project milestones and product functionality.

  • Plays primary technical role in electrical design, test, and documentation to meet compliance and product requirements and satisfy customer needs of a medical device system.
  • Works independently as well as with the functional and project teams to develop technical solutions to complex problems that require ingenuity and creativity.
  • Leads troubleshooting and problem-solving efforts related to electrical active implantable and / or external instruments and associated systems. Supports and communicates decisions through thorough engineering practices and data analysis.
  • Creates and communicates design/test plans, tasks, deliverables and status. Manages time and resources to meet committed schedule milestones.
  • Participates or leads in the definition of product /design requirements, electronic system architecture development, design and implementation of electronic circuits, test of circuits and systems and the documentation and release of designs.
  • Responsible for generating or improving electrical designs that are optimized for production, reliability, regulatory compliance, and cost.
  • Follows documented design processes to meet regulatory and company requirements. Responsibilities include generating engineering documentation for a design control process in a regulated environment.
  • Interfaces with vendors, manufacturing, and other internal groups, and provides work direction to contractors, lab personnel and other technical staff while executing design tasks. Mentors and provides technical assistance as required.

Required:

  • Bachelor’s degree in Electrical Engineering, Physical Science, Computer Science or related discipline.
  • Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years relevant experience.

Preferred:

  • MS in Electrical Engineering with a minimum of 7 years engineering experience.
  • Knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards.
  • Knowledge of standards and directives such as IEC 60601, IEC 61010, UL, ANSI and ASTM, RoHS/EE/WEEE.
  • Prior relevant experience as a technical lead or team lead role.
  • In-depth understanding of medical devices systems utilizing embedded software.
  • Task planning, sub-team management and leadership skills and experience.
  • Knowledge and experience in design of embedded microcontroller-based electronics devices, including FPGA-based, digital, and analog design.
  • Experience developing Class II and Class III medical devices.
  • Experience with key technologies such as inductive telemetry, wireless and wired charging, thermal modeling, BLE, boost power supply design in a neuromodulation system
  • Experience in the evaluation of electrical stimulation waveforms for neuromodulation therapy.
  • Experience evaluating and reporting key electrical design parameter performance and providing input for design improvement in terms of DFM using common test equipment: oscilloscopes, signal generators, multimeter, current meters, LCR meters, power supplies.
  • Knowledge and experience using CAD systems for printed circuit board design (e.g. Altium, Cadence, OrCAD, Allegro PCB) and data acquisition software (LabVIEW).
  • Altium Designer experience with creating and maintaining component symbol libraries and component land patterns.
  • Experience with PCB layout using Altium Designer tools. Experience creating design packages for contract manufacturers including electronic layout design, FAB and ASSEMBLY drawings BOMs.
  • Experience/knowledge of soldering methods, printed circuit board design and layout guidelines (IPC).
  • Experience testing electronic devices to meet immunity and emissions requirements.
  • Experience in developing verification and validation protocols
  • Working knowledge of Microsoft Office tools.
  • Communication, presentation, technical writing and organizational skills.
  • Familiarity with systems, mechanical and software engineering disciplines.
  • Familiarity with manufacturing processes, quality assurance, reliability assurance, clinical, risk management.
  • Experience with networking and wireless technologies.
  • Experience using statistical analysis software to prepare test data for regulatory review (e.g. Minitab, MedStat)
  • Experience writing test protocols for standards and radio compliance for a Class III medical device (active implantable).
  • Experience incorporating design for manufacture techniques to improve yields.
  • Experience with component qualifications, including using external manufacturers to build custom components.
  • Experience managing component inventories both internal and at external manufacturers.
  • Experience performing operational inspections of PCBAs using common test equipment: oscilloscopes, signal generators, multimeter, current meters, LCR meters, power supplies.
  • Experience in management of test equipment calibration.
  • Experience with implementing ESD requirements within the laboratory workspace.


Posted: November 3, 2020, 8:01 am
Category : Technical Writer
Job Type : Contract
Id : 8049
Region : Twin Cities

The Engineering Technical Writer creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, web based publications and user sites; may produce content for embedded user assistance technology. This position conducts interviews with various users and technical staff to gather data for documentation. Researches and translates technical information into manuals and/or web based documents for nontechnical and technical users. May document engineering processes and specifications. Recommends formats responsive to technical and customer requirements. Produces products that conform to the company documentation and quality assurance standards.

  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 30, 2020, 6:59 am
Category : Production Supervisor
Job Type : Permanent
Id : 8048
Region : Twin Cities

Seeking a Machining Supervisor for the following:

  • Process Engineering Change Orders
  • Set up new part numbers in ERP system
  • Create bills of materials in ERP system
  • Create routings for saw, laser, TimeSaver, welding, brake press and outside operations in ERP system
  • Supervise saw, laser, CNC machine and brake press operators
  • Monitor performance of direct reports. Provide coaching and direction when needed to achieve expectations
  • Create programs for CNC machines
  • Select tooling for all machine centers
  • Work with operators to trouble-shoot process issues
  • Coordinate building maintenance activities
  • Coordinate annual crane inspections
  • Nest parts for laser cutting operations
  • Provide Project Engineers with cost estimates for manufactured parts and participate in the make/buy decision


Posted: October 29, 2020, 12:03 pm
Category : Systems Engineer
Job Type : Contract
Id : 8040
Region : Twin Cities

The Systems Engineer performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. This Engineer ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Also, performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 27, 2020, 9:48 am
Category : Reliability Engineer
Job Type : Contract
Id : 8038
Region : Twin Cities

The Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs for a major medical device company.

  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 27, 2020, 7:21 am
Category : Quality Engineering
Job Type : Contract
Id : 8028
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: October 26, 2020, 8:24 am
Category : Software Engineering
Job Type : Permanent
Id : 8033
Region : Twin Cities

We are looking for a Senior Embedded Software Engineer to join our software team. A Senior Embedded Software Engineer is responsible for the architecture and implementation of embedded software for sensors. A Senior Software Engineer generally works at the direction of a Software Architect or Systems Engineer.

Core Responsibilities:

  • Design and implement embedded software for various sensor projects including new product development.
  • Design and implement unit tests and stress tests for validation of embedded software.
  • Document firmware architecture and communications interfaces.
  • Work closely with Electrical Engineering to debug and troubleshoot PCBA’s during board bring up, utilizing electronics troubleshooting tools such as logic and protocol analyzers and oscilloscopes.
  • Work closely with Software Engineering as they develop PC applications to control the sensors.
  • Provide support for legacy sensors, including designing and implementing solutions to challenges found in the field.

Experience, Education and Competencies Required:

  • BS Degree in Computer Science or Electrical Engineering (or similar).
  • 5+ years developing applications on custom electronic hardware.
  • Proficiency in C and C++ programming on embedded systems.
  • Strong electrical background and proficiency in reading electronic schematics, component datasheets.
  • Working with multi-discipline engineering teams throughout all phases of development.

Preferred Experience:

  • Embedded Linux development using Yocto and Bitbake, including driver development, integrating patches, Bitbake layer and recipe generation, and U-Boot.
  • Real time (super loop) firmware for micro-processors using SPI, I2C, UART, and SDIO to communicate with peripheral sensor IC’s.
  • Wireless communication protocols Bluetooth classic and WiFi (TCP/IP).
  • Wired communication over USB and Ethernet.
  • Image processing and other digital signal processing in an embedded environment.
  • Git and Microsoft TFS version control.


Posted: October 19, 2020, 1:58 pm
Category : Mechanical Designer
Job Type : Contract
Id : 8016
Region : Twin Cities

The Mechanical Designer will be responsible for design of special machines, fixtures, and automated production equipment.

Prefer a 2 year degree in mechanical design and 5 to 10+ years of hands on automated equipment design experience, from concept through detailed design.

Requirements include strong SolidWorks design skills, and experience in one or more of the following areas: product packaging or assembly equipment, dial and indexing systems, robotics, motion control, for manufacturing equipment. Ability to specify components, drives, material handling systems, pneumatics, and related automation components is required, and experience with medical / pharmaceutical equipment design preferred.


 

Posted: October 7, 2020, 2:41 pm
Category : Sales Engineer
Job Type : Permanent
Id : 8013
Region : Twin Cities

Seeking an Applications Engineering Manager to lead the Sales Applications Engineering team (5-7 members) as a key part of the sales group. This includes managing, coaching, training, strategic quoting and also performing some Applications Engineering functions (player/coach role) in a manner that will positively impact successful sales pursuits and help the team achieve sales goals, customer satisfaction and enhance the reputation of the company.

Qualifications:

  • Bachelor’s degree or equivalent in engineering or suitable physical science degree.
  • At least 5 years of experience in a sales and application engineering sales support capacity, most of which should involve automation and/or electro-mechanical products.
  • At least 1 year of experience in a supervisory role. Ability to lead and influence others in a confident, positive and results-oriented manner. Ability to identify and organize effective training to continue to enhance the team’s skill set.
  • Experience in sales or sales support to design, specify and quote new projects and tied to a sales target. Has significant experience making sales calls in the field and troubleshooting with customers on-site and over the phone/computer.
  • Desired functional knowledge of mechanical actuation and electrical motors or PLC programming.
  • Must exhibit a strong technical aptitude and ability to read and interpret engineering data as applicable to the company’s product line and an interest/ability to learn technologies and product.
  • Strong computer skills including the ability to use Microsoft Office based products, be familiar with some CAD drafting products and have an ability to learn some motor/drive programming.
  • Ability to communicate effectively, both verbally and in writing, with a wide variety of distributors, customers, prospects, company personnel and others. An ability to work effectively on the phone and video conferencing with a wide variety of sales people and customers in both a sales and troubleshooting capacity.
  • Ability to effectively train both internal employees and external customers.


Posted: October 6, 2020, 7:17 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8011
Region : Twin Cities

The Biomedical Engineer designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.

  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 6, 2020, 6:15 am
Category : Quality Manager
Job Type : Contract-to-Hire
Id : 7993
Region : Twin Cities

We are seeking an experienced Quality and Documentation Manager to help redevelop and maintain our ISO 9001 quality management system, quality assurance as well as documentation control.

Responsibilities:

  • Work with management, engineers and floor employees to assess current engineering and production practices and improve as necessary.
  • Drive design/process capability evaluation
  • Develop quality metrics for our products and processes
  • Manage Engineering change orders and process changes, receiving inspection/Final inspection process/documentation, CoCs, deviations, internal and external corrective actions and audits.
  • Responsible of the Documentation Control and Quality Management System policies and procedures.

Qualifications:

  • B.S. in Quality, Manufacturing, Business Administration or equivalent
  • A minimum of 5 years related experience required.
  • Contract manufacturing, ISO 9001, ISO 13485, IATF 16949 experience required
  • Quality and Documentation Control Management expertise
  • Quality Assurance expertise
  • Excellent communication skills


Posted: September 21, 2020, 1:41 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7982
Region : Twin Cities

Seeking a Sr. Electrical Engineer to be responsible for the development of new products, including electronic architecture design, detailed circuit design and analysis, prototyping, implementing designs, test, and discovering innovative solutions to complex problems and systems.

Primary Responsibilities:

  • Performs detailed electronic designs for electronic components, products, or systems for commercial, industrial, medical, military, or scientific applications.
  • Analyzes customer needs and determines electrical system requirements and cost to develop a system plan. Ability to evaluate current systems/processes to recommend design modifications or equipment repair/updates.
  • Develop testing procedures for electronic components and equipment; includes leading and supporting prototype build and test activities.
  • Writes technical documents such as design specifications, verification test plans and reports.
  • Plans and develops applications and modifications for electronic properties used in parts and systems to improve technical performance.
  • Develops reliable, cost effective, manufacturable electronic products from initial studying of customer requirements through conducting and documenting design validation and verification activities.
  • Performs circuit analysis, simulations and concept/feasibility design activities.
  • Conducts design analysis on components and/or assemblies.
  • Creates detailed block diagrams & circuit schematics.
  • Leads and/or supports printed circuit board layout and/or other product activities.
  • Practices good engineering design process; version control, lead design reviews, documented design history, complete projects within budgetary and scheduling goals.
  • Works and communicates with management team, engineering team, and/or project managers to ensure projects are completed satisfactorily, on time, and within budget.
  • Supports project planning and project proposal efforts.
  • Presents verbally in one-on-one or group settings.
  • Responsible for following all ISO quality systems and procedures.

Education/Experience:

  • Bachelor of Science in Electrical Engineering or equivalent; or five to ten years related experience and/or training; or equivalent combination of education and experience.
  • Experience with Altium schematic capture and PCB layout
  • Must have experience working with microprocessor-based platforms, analog and digital circuits, and experience with sensitive analog circuit design and analog design tools such as SPICE.
  • Knowledge of signal integrity concepts, simulation tools, and with compliance and regulations, i.e. IEC 60601-1 and ISO 14971 risk management, highly desired.
  • Bachelor's degree and experience in new product development, ranging from requirements development to prototyping, to verification and product release, preferred.
  • Experience in medical device and/or other regulated industries, and project management experience preferred.


Posted: September 3, 2020, 7:40 am
Category : Project Manager
Job Type : Contract
Id : 7715
Region : Twin Cities

Seeking a Project Manager to lead and ensure a successful execution and closure of assigned projects.  The successful candidate will manage scope, schedule and budget of assigned projects.  Be the single point of contact for all assigned customers projects and be Proactive Project Risk Mitigation.

 

Key Responsibilities:

  • Single point of contact for assigned projects from Order Launch through shipment.
  • Facilitate review of customer specifications and quotes such that the scope of work is defined.
  • Estimating, quoting, and documenting change(s) in scope to customer.
  • Direct communication to align and reconcile project expectations with deliverables.
  • Collaborate in assembling project financial plan, monitor the plan and drive for corrective action when plan is in jeopardy.

 

Additional Responsibilities:

  • Work with customers to correct measurable, significant lapses in plan.
  • Provide ongoing support after shipment as necessary, until customer is completely satisfied.
  • Arrange and facilitate all customer visits during duration of project.
  • Obtaining from customer all that is needed for our completion of project: specifications, test material, floor plan sign offs, payments, etc.
  • Coordinates project work plan for successful project completion.

 

MINIMUM JOB REQUIREMENTS:

  • Bachelor's degree in related field or equivalent experience
  • Experience in a fast paced, engineered to order, manufacturing environment
  • Five years of experience in a project management position.
  • Demonstrated technical competency with product line
  • Highly organized and good at managing details
  • Exceptional presentation skills
  • Aptitude to deal directly with customers effectively in high pressure situations, not conflict-adverse
  • Proactive on follow-up, not letting issues linger
  • Exceptional written and verbal communications skills
  • Proven ability to plan
  • Good negotiator (searches for "win-win" solutions)
  • PMP or similar certificate desirable

 

Posted: August 7, 2020, 11:25 am
Category : Software Engineer
Job Type : Contract
Id : 7965
Region : Twin Cities

Looking for a Software Engineer to develop and support existing machine vision inspection systems and custom automated control systems used in the development and production of medical devices. Will work within equipment/software engineering group to design machine vision systems, including concept, plans, programming, and troubleshooting for complex manufacturing and test equipment. Requires BS (CS or EE) and prefer 3 - 5+ years of experience with automated equipment development, including some hands-on vision system knowledge. Must have strong experience with .NET and C# programming and understanding of automated equipment design. Prefer experience with SQL and Cognex Vision system development. Exposure to robotic systems a plus.

 

Job Responsibilities:

  • Investigate machine vision software to identify opportunities to increase yields and/or quality of the vision system.
  • Determine root cause with regard to machine vision inspection issues.
  • Update machine vision software for enhancements and bug fixes of existing systems.
  • Investigate machine vision lighting solutions to enhance existing inspection systems.
  • Collect and analyze inspection results to prove robustness of vision system changes.
  • Integrate machine vision software system into a PC or PLC based system.
  • Troubleshoot machine vision and controls systems using pneumatic and electrical schematics.
  • Develop/Update departmental standards.
  • Create supporting design documentation.
  • Make software modifications to existing automated controls equipment.
  • Follow departmental procedures and processes when updating and developing new systems.
  • Participate on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Communicate costs and project status to project lead.
  • Creates electrical/software designs utilizing the departments' standard development tools and procedures.

 

Posted: July 31, 2020, 1:48 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7964
Region : Twin Cities

Excellent opportunity for a Controls Automation Engineer to support design and programming of manufacturing / test equipment used in the development and production of medical device products. Requires BS degree (EE, CS) and experience in design and programming of complex industrial machine control systems. This includes PLC / HMI programming, control panel / hardware design, and system troubleshooting and start-up. 

  • Prefer 3 - 5 years of experience in automated system design.
  • Prefer experience with Allen Bradley/Rockwell Automation PLC and HMI, robotics, motion control, vision systems (Cognex) programming, and system validation and start-up.
  • Prefer experience with SAP and Manufacturing Execution Systems (MES).
  • Prefer experience working within an FDA (or similar) regulated validation and documentation process preferred, and experience with Visual Basic / .NET  programming and SQL database development is a plus.


Posted: July 31, 2020, 1:42 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7798
Region : Twin Cities

Seeking a Senior Embedded Software Engineer to design & develop reliable, maintainable, testable software for products used in a wide variety of applications based on 8/16/32/64-bit and multicore processors running no operating system to embedded RTOS, Linux, Windows, etc..

 

Responsibilities:

  • Participate in overall system design and analysis activities from new product concept and customer requirements to risk analysis to verification and validation.
  • Create, document and maintain software architectures.
  • Code, debug and test software on a wide variety of platforms and operating systems.
  • Write and maintain software specifications, plans and reports.
  • Follow documented software processes and contribute to continuous process improvement.
  • Work and communicate with leaders, engineers and project managers to ensure project completion.
  • Support project planning and project proposal efforts.
  • Present verbally in one-on-one or group settings.
  • Other duties as assigned.

 

Requirements:

  • Minimum Bachelor of Science in Electrical Engineering, Computer Science, Software Engineering or equivalent (Master's degree preferred).
  • Minimum 8+ years of experience in new product development.
  • Experience with the product development process ranging from requirements development, prototyping, verification and product release.
  • Must have significant experience developing software in C and/or C++ for embedded systems.
  • Experience with basic software and hardware debug tools (JTAG debuggers, oscilloscopes, etc.).
  • Experience working in teams with multiple engineering disciplines and external 3rd parties.
  • Strong verbal and written communication skills including the ability to write technical specifications and design documentation.
  • Ability to manage multiple priorities.
  • Ability to provide leadership and guidance to junior level staff.
  • Ability to work in a fast paced environment with quickly changing priorities.

 

Desired Experience:

  • Experience in medical device design or other regulated industries.
  • Working with implantable devices.
  • Leading software projects; i.e. project manager, project lead etc.
  • Managing project budget, schedule, progress towards milestones
  • Experience with software processes compliant with IEC 62304.
  • Writing and executing software unit, integration and verification tests.
  • Writing requirements from high level customer needs to detailed specifications.
  • Risk management activities compliant with IEC 14971.

 

 



Posted: July 15, 2020, 12:03 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7856
Region : Twin Cities

Immediate opportunity for an Automation Build Technician to support equipment build projects for medical device manufacturing.

 

The Technician will assemble, test, and troubleshoot custom automated equipment and work cells.  This includes electrical control panel wiring, motors, drive systems, mechanical enclosures, and PLC installations and check-out.

 

Preferred Skills:

  • 2 year degree in Electronics or Automated Systems Technology
  • Hands on experience with equipment build
  • Must be able to read prints, schematics, and work instruction
  • Strong mechanical and electrical aptitude
  • Ability to work independently within a custom automation group
  • Knowledge and experience with PLC, HMI, and motion control
  • Medical device development environment experience is a plus

 

Posted: February 28, 2020, 1:47 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7776
Region : Twin Cities

Seeking a Production Technician to support Semiconductor sensor products.  The Production Technician will support engineering with moderately complex engineering duties and/or hands-on tasks. Involved with the overall production and manufacturing of optical sensors or Semiconductor. Coordinate with hardware and software manufacturing engineering teams. Assist in the develop performance models and test procedures.

 

Key Responsibilities and Essential Functions:

  • Build, align, and calibrate sensor using hand tools, light meters, multimeters, alignment telescopes, autocollimators, theodolites, and lasers.
  • Support Design Engineers with testing and troubleshooting. Analyze test results and adjust equipment to bring it within specifications. Set up and conduct precision optical and mechanical measurements.
  • Coordinate with other departments to install, align, troubleshoot, calibrate, and document changes.
  • Participate in daily production communication meeting to resolve manufacturing issues such as process, fixtures, capacity, and materials to achieve the production build plan.
  • When required, candidate can be assigned to support production capacity to meet revenue plans.
  • Proficient with computer programs like MS Outlook, MS Word, MS PowerPoint, and MS Excel to communicate, calculate, and document.
  • Ability to read mechanical drawings, production build processes, and test procedures.
  • Work closely with APA (Advanced Prototyping Assembler) & Manufacturing Engineering team.
  • Required work hours is from 6:00am to 2:30pm with flexible hours to work outside of standard hours.
  • Other duties as assigned.

 

Experience, Education, and Competencies Required:

  • Two year technical degree in manufacturing or related field with two years of hands-on experience.
  • Ability to understand drawings, specifications, procedures, and geometric tolerances.
  • Self-driven with the ability to multi-task and prioritize within their assigned work scope.
  • Strong troubleshooting skills to decipher between sensor design, fixture, or software issue.
  • Able to articulate problem statement and provide technical strategy to problem solving.
  • Ability to work with minimal supervision, but does not supervise others.  Individual will not give work direction.  Will provide input to create a solution for process change considerations to be approved by the Manufacturing Engineer or Production Supervisor.
  • Experience, Education, and Competencies Preferred:
  • Five years of optics or semiconductor hands-on experience.
  • Optical component handling, cleaning, and bonding experience preferred.
  • Experience with optomechanical / electromechanical assembly operations preferred.
  • Working knowledge of small to medium electro/mechanical assembly experience.


Posted: November 4, 2019, 11:51 am
Category : Project Manager
Job Type : Permanent
Id : 7765
Region : Twin Cities

Seeking a Project Manager to be the primary customer interface during all project phases of design, supply, production, factory testing, delivery, install, and customer site acceptance testing. This individual will be responsible for project leadership on build to print and custom automation design and build projects.

Responsibilities:

  • Provide leadership to drive project related decisions (technical & non-technical)
  • Develop detailed project plans and specification documents
  • Identify resources by discipline required for successful project milestone deliveries.
  • Work with organization management on early identification and labor durations of project resources
  • Plan and lead all internal and customer project design reviews throughout project execution
  • Execute project plans which are designed to exceed financial targets
  • Manage quality, schedule, cost, and customer satisfaction
  • Manage contract compliance as it relates to "as sold" scope, allowable deviations, scope changes requiring purchase order adders, timely release of invoicing, and payment receivables

Requirements:

  • Ideal candidate will have the ability to manage multiple projects of varying degrees of complexity simultaneously, proven leadership, planning and organizational skills, and strong technical background in automation design.
  • Candidate must demonstrate proven "systems" approach to project management and the drive to consistently deliver on commitments.
  • Qualified candidate will have a BS or MS in Engineering or Technical discipline and 8-10 years of relevant experience. Significant team leadership experience, preferably in a project environment, is desired.



Posted: October 11, 2019, 11:09 am
Category : Controls Engineer
Job Type : Contract
Id : 7725
Region : Twin Cities

Seeking a Controls Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Position Requirements:

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: August 28, 2019, 12:46 pm
Category : Controls Engineer
Job Type : Permanent
Id : 7556
Region : Twin Cities

Seeking a Systems Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Requirements

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: December 6, 2018, 9:22 am
Category : Sales
Job Type : Permanent
Id : 7488
Region : Twin Cities

Development Resource Group is a fast-paced, well-established engineering staffing firm seeking a motivated and energetic individual to join our growing recruiting team. Development Resource Group has been supplying contract and direct hire technical staffing since 1986 specializing in Medical Device, Engineering, R&D, and Product Development.

DRG specializes in placement of hardware, software, and mechanical engineering personnel on projects with many high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing of products for medical device, electronic products, and automation systems.

The Technical Recruiter must have excellent communication skills, a high level of computer system knowledge, and preferably direct experience in sourcing, interviewing, and placement of high-level product development engineers.

We are seeking an individual to manage the full recruiting lifecycle: sourcing, screening, interviewing, reference checking, and negotiating employment terms. The candidate will be well versed in all aspects of professional recruiting, including networking and the recent trends in hiring.

Ideal candidates will be skilled in the use of applicant tracking systems and be self-sufficient in navigating and administering the applicant flow process.

Prefer BS degree, with proven track record of success in the staffing industry.

We offer excellent earning potential, a competitive benefit package, and an opportunity to be successful in the fast-paced, growing technical staffing industry.


 

Posted: September 6, 2018, 9:34 am
Category : Sales
Job Type : Permanent
Id : 7487
Region : Twin Cities

Development Resource Group is a growing Technical Staffing firm located in Mounds View, MN. Since 1986, DRG has been assisting clients in locating experienced engineers for project-based work on a temporary, contract-to-hire, or permanent basis. We specialize in placement of hardware, software, and mechanical engineering personnel with a strong base of high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing for medical device products, electronic products, control products and automation systems.

We are seeking a motivated and energetic individual to add to our Sales Team as an Account Representative. Account Representatives are responsible for working with our clients in establishing their needs and then working with our recruiting staff to fill those needs. Additionally, they support all contracted staff though the duration of their project, working to ensure both client and contractor's satisfaction. Candidates must have excellent communication skills, a high level of computer systems knowledge, technical staffing experience, be self-motivated and enjoy working in the "people business." A college degree is preferred, with several years of staffing sales experience and/or recruiting experience in a Technical or Engineering field.

We offer an enjoyable working environment with a proven track record in our industry, excellent earning potential, a very competitive benefits package and an opportunity to be successful in the fast-paced, growing technical staffing profession.



Posted: September 6, 2018, 8:20 am