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Development Resource Group

Get updates on all the job openings from Development Resource Group.

Category : Technicians
Job Type : Contract
Id : 7408
Region : Twin Cities

Seeking a Production Engineering Technician to be part of a team that supports production by improving yields, increasing capacities, and efficiencies. This Technician will take direction from Production Engineers in the support of device/ board level failure analysis, data collection, build of test/ semi-automation fixtures, and other tasks as needed. PE Technicians are encouraged to be creative & innovative, while at the same time learn and follow the corporate structured processes.

Responsibilities:

  • Test and troubleshoot of electronic systems at device and board levels
  • Printed circuit board troubleshooting to include both surface mount and through hole
  • Support failure analysis investigations/ data collection as directed by Production Engineers
  • Support development, build, and validation of manufacturing test/ semi-automation equipment
  • Some mechanical fixturing and assembly
  • Assist with other technical tasks as requested

Qualifications:

  • Two-year Tech degree or higher preferred
  • 2 years technical experience with a preference for the medical or military or avionics industry
  • Ability to read electrical schematics and troubleshoot to the component level
  • Familiarity with analog/ digital circuits including sensors, A/D conversion, filtering, and RF preferred
  • Skilled in the use of electronic test & measurement equipment and in soldering/ desoldering of electronic components
  • Strong analytical and problem solving skills
  • Familiarity with Excel & Word preferred
  • Strong interpersonal, teamwork, and communication skills


Posted: June 20, 2018, 1:54 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7406
Region : Twin Cities

Seeking a Smart Home Device Engineer to be responsible for MCU based design of smart home devices for the IoT ecosystem (i.e. - smart power outlets, motion sensors, lighting control, etc.)

Required Experience:

  • Experience deploying smart home products
  • Need to be both hardware and firmware capable
  • PCB layout using Altium
  • Firmware programming in C
  • Knowledge of Google Home "Build Actions" for Google Assistant is a plus but not mandatory


Posted: June 20, 2018, 9:52 am
Category : R&D Engineer
Job Type : Contract
Id : 7407
Region : Twin Cities

Seeking a Sr. Chemical Engineer to provide engineering support as part of a global team tasked with design and development of an innovative dialysis system. This position will design, plan and execute experiments to define demonstrate basic feasibility, develop requirements and evaluate design concepts. This position will spend majority of time working in the lab under general direction from project leadership.

Main Job Duties/Responsibilities:

  • Provide engineering expertise as part of a cross functional team conceiving, evaluating and developing a novel dialysis system.
  • Design, plan and conduct research to evaluate feasibility of the targeted product.
  • Design, simulate and construct prototype devices for proof of concept, animal, and human studies
  • Ensure that device concepts and development plans meet targeted clinical application through systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
  • Apply established SOP's and/or develop new processes, as needed, to ensure that newly developed devices meet established requirements and, where necessary, are approvable under applicable regulatory requirements

Position Requirements:

  • Minimum of BS in Chemical Engineering or related field and 5-10 years experience.
  • 3+ years of direct experience developing small scale, continuous or semi-continuous processes involving inline chemical mixing and reaction
  • Working knowledge of water purification and filtration technologies
  • Self-starter with strong work ethic and initiative in accomplishing objectives
  • Strong organization and time management skills; ability to manage multiple priorities and work under tight deadlines
  • Attention to detail, thoroughness
  • Strong written and verbal communication skills
  • Able to work in cross-functional and cross-cultural teams

Preferred Qualifications:

  • MS degree with 5-10 years experience
  • Experience working in medical device, pharmaceutical or other regulated industry.



Posted: June 20, 2018, 9:47 am
Category : Electrical Engineer
Job Type : Contract
Id : 7405
Region : Twin Cities

Seeking a Motor Control Engineer to be responsible for MCU based design of BLDC and DC motor controls, up to 200 Amps per channel.

Required Experience:

  • Need to be both hardware and firmware capable.
  • PCB layout using Altium
  • Firmware programming in C
  • Knowledge of J1939 protocol is a plus but not mandatory



Posted: June 20, 2018, 9:31 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7403
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer to provide design continuation engineering support for Implantable Medical Device products including Instruments. Engineering support may be independent or under the direction of a lead engineer and/or project manager. The key at being successful in this job is the ability to multi-task, work effectively cross functionally, drive projects to closure within specified milestones and be flexible on project assignments. The engineer will be a key member of design changes that improve manufacturability, quality, reliability, safety and reduce cost. The engineer may support or potentially lead corrective action teams to resolve quality issues. Engineers that thrive on variety and flexible project assignments will enjoy this position.

POSITION REQUIREMENTS:

  • BS in Mechanical Engineering (BSME) or BS Biomedical Engineering
  • Minimum 5 years relevant engineering experience in design or product development (relevant internship experience will be considered)
  • Ability to work independently with minimal oversight following defined product development processes and completing tasks on time

PREFERRED SKILLS:

  • Understanding of regulatory requirements and processes strongly desired
  • Understanding manufacturing processes and quality systems is beneficial
  • Good written and oral communication skills
  • Ability to effectively lead projects or project elements in a cross functional team environment
  • Strong presentation skills
  • Strong technical writings skills
  • A high level of computer competency, problem solving skills, time management skills, strong team work and multi-tasking skills are strongly desired
  • Knowledge and experience using DFSS/Six Sigma is a plus


Posted: June 19, 2018, 1:28 pm
Category : Production Supervisor
Job Type : Permanent
Id : 7402
Region : Twin Cities

Seeking a Production Supervisor that provides leadership and coaching to establish a cohesive and positive results driven team. This candidate will assist in driving culture change to promote continuous improvement and increased team capabilities with engagement to coach and mentor production team members in a fast paced manufacturing environment. This candidate will provide work direction to the production department to ensure the product produced meets or exceeds quality standards and is completed by scheduled ship date.

Key Responsibilities:

  • Maintains a safe and controlled manufacturing environment by educating and directing production team members on the use of all control points, tools, and resources; maintaining compliance with established policies and procedures.
  • Plans, develops and implements new methods and procedures designed to improve operations, minimize operating costs and effect greater utilization of labor and materials
  • Set production cell priorities by understanding business product flow from parts, build, test, packaging, and ship.
  • Interfaces with entire organization to ensure customer deadlines are met. This position will work closely with the Master Scheduler, Buyers, Customer Service Manager and Program Management.
  • Identify, troubleshoot and resolve bottlenecks, process failures, production procedures, staffing issues, supply chain part shortage problems, and/or training deficiencies
  • Establish process, protocol and involvement for new product transition for production release

Position Requirements:

  • Two year degree in manufacturing or related field.
  • Minimum of 5 years of supervisor experience in a manufacturing environment or 3 years of experience with a BS degree.
  • Experienced in Lean manufacturing by using strong influence capability and ability to divert decision making.
  • Familiar with production work orders or schedules to meet customer delivery and quarterly revenue.
  • Experienced in ERP system (QAD). Proficient in Microsoft Excel, Power Point, and Word.

Preferred Qualifications:

  • Familiar with optomechanical / electromechanical assembly operations.
  • Tracked record of supervisor experience.
  • Coach and mentor production team members’ disciplinary but in a professional manner.
  • Having a continuous improvement mindset to bring innovative ideas to the organization.
  • Preferably a 4 year degree in manufacturing, business, or related field.


Posted: June 18, 2018, 11:40 am
Category : Electrical Assembler
Job Type : Permanent
Id : 7401
Region : Twin Cities

Seeking an Electrical Technician / Wire Technician to assemble and wire electrical control panels. Must have the ability to read electrical prints, good electrical wiring skills, and ability to work independently. Knowledge of UL508A standards is desired.

RESPONSIBILITIES:

  • Assembly & wiring of electrical control panel
  • Good electrical panel wiring skills
  • Ability to work independently or part of a larger project team
  • Ability to read electrical prints

REQUIRED:

  • High School Diploma or GED
  • Experience in assembly and wiring
  • Ability to use hand tools
  • Good communication skills
  • Ability to prioritize and multi-task
  • 5+ years prior experience

DESIRED:

  • Knowledge of UL508A standards


Posted: June 15, 2018, 2:50 pm
Category : Quality/Regulatory
Job Type : Permanent
Id : 7400
Region : Twin Cities

Seeking a Regulatory Compliance Engineer to provide worldwide expertise and support related to applicable product safety, regulatory and compliance requirements to ensure Company products are safe and conform to all applicable international regulatory and customer requirements.

Core Responsibilities:

  • Develop, maintain and document effective product and regulatory compliance processes and procedures to prevent and/or resolve product impacts to customers while minimizing business risk
  • Collaborate globally and work cross-functionally with other organizations to ensure that product groups can sustain product compliance
  • Review and/or conduct hazard/risk assessments and process hazard assessments (PHAs) related to product designs.
  • Work with engineering to devise test plans and preparation of samples for testing.
  • Work with third party testing facilities to coordinate and execute product testing.
  • Organize and maintain declarations of conformity, technical construction files, and test reports.
  • Work and communicate effectively with engineers, technical specialists, and management, cross functionally, in a multi-disciplinary, global environment
  • Interact with regulators, outside agencies, industry trade groups/associations and customers as required.

Position Requirements:

  • B.S. degree in Science or Engineering (electrical, mechanical, chemical).
  • 10+ years product safety and regulatory compliance experience with high-tech industrial equipment.
  • Professional certifications desired, e.g., CSP, CIH, PE

Required Knowledge:

  • EMC regulations and test methodologies applicable to electronic and capital equipment.
  • International Radio Frequency compliance standards like FCC and EU RED as it relates to wireless Bluetooth and Wi-Fi products.
  • Industry standards, regulations and certifications that impact Company products such as the CE Marking directives; EU Machinery, Low Voltage, EMC, RoHS, and Packaging directives; Global Product Safety, Battery, and RED Directives; IEC/EN/UL Standards e.g. IEC 60204, EN292, UL61010A, etc.; product-related laser standards & requirements – ANSI Z136, FDA-CDRH & IEC 60825; and EU and country specific chemical, REACH, RoHS, WEEE, and SVHC requirements.
  • Concepts and business processes related to product development, process hazard assessment, engineering design changes, field event reporting, document change control, design review and evaluation processes, risk assignment and management, in a high-tech, large equipment, manufacturing environment - preferably the semiconductor industry.



Posted: June 15, 2018, 9:46 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7399
Region : Twin Cities

Seeking a Senior Quality Assurance Engineer to assure products, processes, and quality records conform to quality standards and establishes compliance with the quality system.

Responsibilities:

  • Maintaining a strong collaborative partnership with cross-functional team members that facilitate 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.
  • 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 SJM 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.

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.


Posted: June 14, 2018, 7:44 am
Category : Software Engineer
Job Type : Contract
Id : 7398
Region : Twin Cities

Looking for an Embedded Software Engineer for design and development of medical software and instrumentation.  Embedded software development is the key responsibility along with test, troubleshooting, and documentation.

 

Qualifications:

  • Experience in a medical product development environment
  • Software design experience with C in an embedded environment
  • Software design experience with embedded RTOS (SafeRTOS preferred)
  • Software design experience in an embedded Linux environment
  • Experience with IEC 62304 is highly desirable
  • BS in Electrical Engineering or Computer Science
  • 3-5 years relevant work experience

 

Responsibilities:

  • Write embedded software in a microprocessor-based embedded environment
  • Design and documentation of embedded software for medical products


Posted: June 14, 2018, 6:27 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7397
Region : Twin Cities

Seeking a Quality Engineer to work with cross functional teams to ensure compliance to LifeScan software development procedures and industry regulations. Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis. Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Occasionally provide training for select software development activities for LifeScan. Occasionally write and execute test protocols and reports.



Posted: June 13, 2018, 7:04 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7396
Region : Twin Cities

Seeking a Quality Engineer to initiate medical device quality assurance activities. 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: June 13, 2018, 6:50 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7395
Region : Twin Cities

Seeking an experienced, high caliber Mechanical Engineer to assist in development and sustaining Medical Device engineering projects. This candidate will need to apply engineering and scientific principles to the evaluation and solution of technical problems. This individual will be responsible for detailed mechanical hardware designs, development plans and reports, appropriate test methodology, and design transfers to production. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective and cost-efficient best practices to execute processes; continually evaluates their effectiveness and appropriateness.

Duties and Responsibilities

  • Performs system design of capital equipment devices. Selects components, processes and proposes design alternatives.
  • Designs hardware to support features that are contained in the product definition. Develops hardware design specifications and is responsible for technology selection.
  • Assists the product definition team with feature selection.
  • 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.
  • Completes component and system designs using Solidworks. This includes setting and revising requirements and specifications, developing bill of materials, and completing documentation to ensure feasibility and verification of design performance.
  • Plans, coordinates, and assists in executing the activities of development teams in support of project goals.
  • Effectively communicates the project successes, risks, and roadblocks to the appropriate management levels.
  • Performs analysis of the product using both empirical and computational models to help identify and mitigate product and project risks
  • Conceptualizes new designs using technical expertise and innovative approaches.
  • Interfaces with various internal functions, outside consultants, vendors, and the medical community.
  • Supports animal studies, bench testing, clinical evaluations, and production
  • Supports technical and design reviews
  • Leads and contributes to strategic initiatives for continuous improvement
  • Solves complex and diverse technical problems by applying sound judgment, creativity, appropriate data analysis, and technical expertise.
  • Establishes product requirements and specifications, including justification and supportive testing to the requirements and specifications, conferring with suppliers to understand manufacturing limits and refine product requirements

Required Experience:

  • Bachelor of Science degree in mechanical engineering or a related field.
  • Experience in relevant hardware design, development, and testing experience, including a general familiarity with manufacturing equipment/processes that are compatible with highly reliable electronic medical or similar devices.
  • 3-D CAD experience (Solidworks)

Preferred Qualifications:

  • Ability to develop and implement novel product concepts as part of new or existing systems.
  • Ability to deliver research information which adds value to management’s decision-making process.
  • Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications.
  • Advanced credential in a relevant discipline/concentration and/or professional certification desired.
  • Statistical analysis, or similar tool sets are preferred
  • Training and experience in manufacturing processes and methods and in the manufacturing of medical devices desired.
  • 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.
  • 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 maintain regular and predictable attendance.
  • Experience with metals (machining, forming) and plastics (molding, machining, forming)
  • Familiarity with IEC 60601 standard is desired
  • Knowledge of electronics is a plus


Posted: June 13, 2018, 6:42 am
Category : Systems Engineer
Job Type : Contract
Id : 7394
Region : Twin Cities

Seeking a Principal Systems Engineer to provide engineering leadership in the design and development of innovative products for Medical Devices through technical planning, system level evaluation, verification and validation. To provide engineering expertise on cross-functional development project teams and collaborate with other external engineering groups.

Responsibilities Include:

  • Fluid system development defining the fluid circuits to support hemodialysis and peritoneal dialysis system
  • Provide engineering expertise in cross functional teams conceiving, evaluating and developing new white space opportunities
  • Develop solid understanding of targeted therapies and clinical applications
  • Ensure that device concepts and development plans meets targeted clinical application through systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
  • Lead, coordinate, execute, and document system analysis and design activities, including but not limited to security, safety, reliability, risk, usability and interface management
  • Establish and advocate for best practices and continuous improvement to mature the Systems Engineering knowledge and processes (CoE)
  • Generate and approve requirements and specifications for all aspects of product concept; ensure that all systems are developed in harmony and support each other.
  • Establish system verification and validation plan(s)
  • Plan and execute system level validation through pre-clinical evaluation.
  • Apply established SOP's, and/or develop new processes as needed, to ensure that newly developed devices meet established requirements and, where necessary, are approvable under applicable regulatory requirements
  • Assess system performance during the development process and provide feedback to these teams
  • Identify, and lead collaborations with internal and external engineering groups
  • Collaborate with quality and regulatory colleagues to ensure compliance
  • Participate in the identification and resolution of complex system issues through interfacing with engineers representing other components
  • Design, simulate and construct prototype devices for animal and human studies
  • Collect, analyze, and model design inputs (voice of the customer, voice of the business, etc.) and transform them into high quality stakeholder and system requirements
  • Provide engineering review on current research projects, device concepts and data.
  • Propose and champion new device concepts

Position Requirements:

  • 8+ years of experience with a Bachelor’s Degree in a technical/engineering discipline; or
  • 6+ years of experience with a Master’s Degree in a technical/engineering discipline; or
  • 4+ years of experience with a PhD in a technical/engineering discipline
  • Development of fluid circuits using pumps, valves, and sensor
  • Solid understanding of fluid circuit control systems

Nice to Have:

  • Significant breadth of knowledge in Quality, project planning, technical expertise, and all areas of product development.
  • Knowledge of dialysis device operation
  • Knowledge of FDA regulations and TÜV requirements


Posted: June 12, 2018, 2:41 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7393
Region : Minnesota

Seeking a Senior Machine Builder with 10 years + experience of building, repairing, installing custom automated machines. The ideal candidate should have working knowledge of:

  • Blue print reading including mechanical, pneumatic and schematic drawings
  • Drafting of detail machine parts
  • Machine assembly
  • Machining
  • Welding
  • Sheet metal work
  • Painting and plating process
  • Field wiring
  • Field plumbing
  • Debug and troubleshooting of automated machinery


Posted: June 12, 2018, 6:24 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7392
Region : Twin Cities

Seeking a Design Assurance Engineer to assure new or modified products conform to quality standards and establish compliance with the company’s quality system. This position will be responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitate organizational success by protecting patient/user safety and meeting business needs.

Job Duties:

  • Execute and support on-time completion of Design Control Deliverables
  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead or support Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support internal & external audit responses
  • Support product re-certifications
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support execution of biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • 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.

General Qualifications:

  • Bachelor level degree in Engineering or Technical Field, advanced degree preferred.
  • 2-5 years’ experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • 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%


Posted: June 11, 2018, 2:50 pm
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7391
Region : Twin Cities

Seeking a Quality Engineer to consult with cross-functional teams to ensure compliance to LifeScan software development procedures and industry regulations. This position will also review and approve deliverables of the software development lifecycle and lead teams in performing Hazard Analysis. This Engineer will occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Also, occasionally provide training for select software development activities for LifeScan. May occasionally write and execute test protocols and reports.

 

Must have experience:

  • Project management
  • Understanding post market surveillance is a plus
  • Change management
  • Technical writing
  • CAPA leadership

 

Posted: June 11, 2018, 1:40 pm
Category : R&D Engineer
Job Type : Contract
Id : 7390
Region : Twin Cities

Seeking a Senior R&D Engineer to be responsible for providing technical 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.

 

Position Responsibilities:

  • Identifies and initiates programs which result in innovative application of existing or new products or technologies.
  • Conduct experiments and/or develop strategies for consideration that extend beyond known scientific and engineering precedents.
  • In order to enhance professional knowledge, the Advisor will review technical documents/publications, attend professional meetings, and interface with suppliers/vendors.
  • As the organization's technical expert, the advisor will provide advice, assistance and direction to project teams and management, when required to assist with problem recognition, review, and resolution.
  • Serves as an advisor on technical acquisitions and new technology development teams.
  • Mentors other employees when appropriate.
  • Provides periodic communication updates to management on future business direction and problem resolution.
  • Publishes scientific papers in professional journals contributing to the advancement of science.
  • Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
  • Conducts feasibility studies to verify capability and functionality.

 

Position Requirements:

  • Bachelor's degree plus 12+ years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.


Posted: June 11, 2018, 1:09 pm
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7388
Region : Twin Cities

Seeking a Principal Quality Engineer who will develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product for medical device manufacturing. 

 

Position Responsibilities:

  • Serve as Project Team Quality Representative and will be accountable for all QA activities associated with each project
  • 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.

 

Position Requirements:

  • Bachelor's Degree
  • Previous Medical Device experience


Posted: June 8, 2018, 1:20 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7386
Region : Twin Cities

Seeking a Principal Electrical Engineer for non-implantable medical devices and related accessories to produce and sustain highly reliable products that provide an excellent customer experience. Experience designing, testing, and troubleshooting analog power electronics is a plus for this role.

Position Responsibilities

  • Be part of a global electrical team to strive for functional excellence in all aspects of daily work.
  • Provide electrical engineering skills to design, develop, analyze, characterize, and debug new product designs including analog and digital circuitry
  • Work closely with design team (electrical, firmware, mechanical) to root cause design issues, create test suites, and characterize and ultimately verify electrical designs
  • Collaborate with a cross functional team to resolve and document issues with fielded product.
  • Design and execute test methods to characterize electrical performance and verify adherence to product requirements
  • Analysis of product performance using DFSS techniques
  • Execute manual and automated tests including fixturing
  • Develop test methods and interface with certified test houses to verify/certify to global regulatory standards including IEC60601, EN45502, FCC, ETSI, etc.
  • Act as a liaison with external suppliers to insure continuity of product supply by resolving supply and quality issues
  • Work under minimal supervision
  • Ensure understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work
  • Ability to work others internationally and travel globally

Basic Qualifications

  • 5+ years of job-related experience with Applicable Bachelor’s Degree (Traditional Institution/Service Academy); or
  • 3+ years of job-related experience with Applicable Master’s Degree (Traditional Institution/Senior Military College)

Desired/Preferred Qualifications

  • BS or MS in Electrical Engineering
  • Experience with designing and debugging electromechanical products
  • Experience with analog power electronics design and troubleshooting
  • Experience with verification and validation of class II and class III medical devices
  • Experience with Design for Six Sigma
  • Experience developing automated test benches utilizing python scripts and/or LABVIEW
  • Experience validating test scripts, methods and systems including IQ/OQ
  • Experience with Altium or OrCAD schematic capture and PCB layout tools
  • Experience with circuit simulation tools such as PSPICE, LTSPICE
  • Experience with international teams and Contract Manufacturers Globally



Posted: June 6, 2018, 7:53 am
Category : Packaging Engineer
Job Type : Contract
Id : 7382
Region : Twin Cities

Seeking a Packaging Engineer to be responsible for the qualification of sterile barrier packaging, updates to engineering drawings, updates to labeling specifications, and support of the packaging team members to complete project tasks.

MAIN JOB DUTIES/RESPONSIBILITIES:

  • Responsible for the qualification of existing packaging systems through EO sterilization
  • Responsible for collaborating with a cross functional team to determine qualification, testing and documentation requirements
  • Manage multiple tasks to meet timelines
  • Responsible for evaluation of materials, design, and configuration of primary, secondary, and other packaging to optimize customer benefit, operations requirements, and the supply chain requirements
  • Draft technical documentation including package testing protocols and validation associated with the qualification of packaging designs
  • Perform other related activities and special projects as needed

JOB QUALIFICATIONS

  • Bachelor’s degree in Packaging Engineering or equivalent engineering degree
  • 0-2 years packaging engineering, or related field
  • Experience working in a team environment
  • Familiarity or experience with EO sterilized packaging
  • Effective verbal and written communication, analytical, influencing and interpersonal skills
  • PC skills, word processing, spreadsheets, project management, etc.
  • AutoCAD/Solidworks CAD software knowledge and experience



Posted: May 30, 2018, 12:32 pm
Category : Quality/Regulatory
Job Type : Contract-to-Hire
Id : 7381
Region : Twin Cities

Unique opportunity for a high-energy Document Coordinator who is able to confidently interface at all organizational levels both internally and externally within an engineering and production environment.

Candidate must: be quality oriented and willing to promote quality standards and adherence to process and procedure; maintain confidentiality of sensitive materials; work independently and hold strong time management skills; be resourceful, flexible, productive and results-driven; display rigor and a strong attention to detail and accuracy; be dedicated and focused on the integrity and success of the business; have the ability to multi-task and complete daily, weekly, monthly, and as needed assignments within allotted timelines.

 

 

Administrative Support;

  • Perform tasks and maintains roles and responsibilities per the mandatory requirements of the Quality Assurance department and per the business Quality Management System.
  • Perform ad-hoc tasks and assignments per the direction of the Director of Operations and Quality.
  • Support office operations as necessary.
  • Provide back-up to the receptionist as needed.

Documentation Support;

  • Organizes and maintains filing systems of operational and confidential information.
  • New project document set-up and design documentation handling.
  • Customer documentation packages and project shipping documentation handling.
  • Engineering change order (ECO) processing.
  • Standard work procedure (SWP) processing.
  • Internal Project Assessment (IPA) set-up.
  • Calibration and preventive maintenance tracking and Tool record keeping.
  • Performs filing and scanning of quality system documentation.
  • Creates and submits Laser Reports.
  • Conducts weekly and as-needed audits and cycle counts.
  • Initiates and tracks new/continued training compliance records for all employees.
  • Management of non-conforming project materials throughout project life cycles.
  • Other duties as assigned.

Qualifications:

  • Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage the completion of multiple tasks and projects.
  • Excellent verbal and written communication skills.
  • Demonstrated proficiency with the most current versions of Adobe PDF and Microsoft Office, including Word, Excel, Power Point, Outlook & Access. 
  • Demonstrated ability to work with all levels of employees within organization.
  • Strong customer focus, excellent service skills, and positive, "can-do" attitude.
  • Knowledge of ISO and GMP regulations desired.
  • 2 or 4 year degree Business Administration or related field or equivalent prior experience.

 

Posted: May 29, 2018, 8:55 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 7372
Region : Twin Cities

Seeking a Senior Mechanical Engineer to be part a team of engineers that develop and support precision, high speed, automated fluid dispensing applicators. Responsibilities include designing and reviewing mechanisms based on piezoelectric, pneumatic, voice coil, cam, flexure and magnetic technology. Emphasis is placed on design and testing methods that assure 24/7 reliability when operated by equipment operators located around the world. In addition, this job involves generating specifications for new products, electronic packaging, thermal design and technical support. Occasional international and domestic travel may be required.

Essential Duties

  • Perform Engineering tasks in the development of new products and cost reduction.
  • Participate in development of Product Specification
  • Produce conceptual designs
  • Create detailed design drawings
  • Provide analysis of design to applicable standards
  • Review instruction manuals and product literature
  • Define and lead prototype development and lab and field tests
  • Work with manufacturing on process development
  • Conduct design reviews, safety reviews, etc.
  • Work effectively in a team environment
  • Provide periodic oral and written reports of project status
  • Troubleshooting product problems in manufacturing, lab, or customer sites

Minimum Qualifications

  • Bachelor’s Degree in Mechanical Engineering
  • Experience with solid modeling systems and mechanical devices
  • 10 years of experience in new product development with demonstrated repeated success producing innovative and successful products

Desired Qualifications

  • Master’s Degree in Mechanical Engineering
  • Five years of experience with fluid dispensing applicators and design
  • Five years of experience with magnetic and piezo-actuated mechanical design


Posted: May 22, 2018, 10:02 am
Category : Project Manager
Job Type : Contract
Id : 7370
Region : Twin Cities

Seeking a Program Manager to be responsible for participating and/or leading various cross functional teams and projects related to productivity, business continuity, cost down, manufacturing transfers and other projects in alignment with the overall Manufacturing and Operations strategy.

Position Responsibilities:

  • Lead large projects yielding productivity and cost reductions in alignment with Company's Operations strategy.
  • Participate and lead projects related to manufacturing strategy project execution and insource/outsource strategy.
  • Collaborate with Sourcing, Finance, Engineering, and Operations project teams to meet financial targets.
  • Lead the analysis of make vs. buy and outsourcing decisions and make recommendations to the Ops PMO.
  • Lead project team meetings and drive completion of team objectives and milestones.
  • Develop, define and execute project plans, schedules, budgets and deliverables where applicable.
  • Assess risk vs. rewards and properly represent and protect Operations with applicable data.
  • Facilitate, participate and lead cross functional teams
  • Coordinates the preparation of proposals, business plans, operating budgets and financial terms/conditions of contracts as applicable.
  • Use tools such as DMAIC process to drive various continuous improvement efforts.
  • Monitor and report progress assessing risk and implementing strategies to ensure successful completion of programs.
  • Assess project issues and develop resolutions to meet productivity, quality and other business objectives.
  • Develop mechanisms for monitoring project progress, intervention and problem solving.
  • Review status of projects and budgets, manage schedules and prepare status reports.
  • Support monthly Ops PMO operating system and assist with process governance.

Basic Qualifications:

  • Bachelor's degree in business or related field
  • 7+ years of Project Management experience

Preferred Qualifications:

  • 5+ years in a highly regulated industry
  • 5+ years in Operations and/or Manufacturing environment
  • Experience in identifying and leading manufacturing transfers
  • Experience supporting and executing cost down/productivity projects
  • Strong business and financial acumen
  • Experience driving continuous improvement with proven business results
  • Knowledge of core manufacturing processes
  • Able to collaborate effectively at all levels in a matrix organization
  • PMP Certification


Posted: May 21, 2018, 2:34 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7369
Region : Twin Cities

Seeking a Reliability Engineer to be accountable to ensure that safety is proactively designed into Company's products/systems and to predict product/system performance against survivability expectations. To enable this, this position is responsible for translating these goals into strategies that drive design decisions, assess the design and establish risk requirements, and ensure that any residual risk is within acceptable limits. The position is also responsible for the execution of these strategies. 

This position is specifically for the remediation of risk management files. The work will involve assessing legacy documentation; and updating hazard analysis based upon new field data, new standards and quality processes for risk management.

POSITION RESPONSIBILITIES: 

  • Analyze designs to: Identify hazards inherent to design, Determine probability of harm due to hazards, Evaluate impact to patient safety , Quantify residual risk: Perform risk/benefit analysis, Maintain risk management file for product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation, Actively communicate findings to Quality, Development, and Operations teams 
  • Analyze product field performance through analysis of complaints 
  • Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, risk management tools and methodologies to drive safety improvements. 
  • Perform systematic risk analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of risk management techniques (e.g. hazard analysis, risk/benefit analysis) to understand product and process robustness. 
  • Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings. 
  • Work on organizational process improvement projects, cross-functional business improvement teams, and develop shared best practices to drive functional excellence. 

 

BASIC QUALIFICATIONS: 

  • Bachelor's in engineering, science or related technical field  and 4+ years experience

PREFERRED QUALIFICATIONS:

  • Experience with ISO 14971 
  • Master's in engineering, science or related technical field 
  • 2+ years Safety or Systems Engineering experience 
  • Experience in medical devices or other highly regulated industry 
  • Experience working in or with Design, Quality and Operations 
  • Experience with risk management concepts and documentation is preferred 
  • Experience with dFMEAs is helpful 
  • Experience with complaint handling and MDRs is useful 
  • Understand therapy (clinical) performance, product function(s), and product use 
    environments to appropriately and strategically apply technical knowledge, analysis tools 
    and methodologies to understand and quantify residual risks 
  • Proficient in word processing, spreadsheets, and managing electronic data files 


Posted: May 21, 2018, 1:34 pm
Category : Manufacturing Engineer
Job Type : Permanent
Id : 7365
Region : Twin Cities

Seeking a PCB Manufacturing Process Engineer to be responsible for defining, developing, and implementing production processes, including workflow, routing, time standards, defining quality metrics and leading process improvement efforts. This position assigns tasks to and directs technical staff and interns on processes and projects. Also, leads complex projects.

 

Duties and Responsibilities:

  • Apply knowledge of electronic assembly processes, Company's production capabilities and Lean manufacturing concepts to develop and implement accurate, achievable and competitive production processes. Provide guidance and training to engineers, technicians, interns and staff on these processes. Actively pursues state-of-the-art knowledge and applies it in these efforts.
  • Establishing and improving production capacity, productivity, and quality. Establish appropriate process controls and metrics.
  • Develop manufacturing documentation, such as process specifications, work instructions, test procedures, and inspection methodology for new PCB and small mechanical assembly processes. Ensure timely documentation maintenance and updates to support new revisions and changes.
  • Develop and Implement Production process development and continual improvement projects. Tasks include appropriate investigations, cost analysis and justifications, equipment selection and installation, purchasing, process validation, installation, and documentation. Develops suitable designs of experiments, budgets and schedules to support these projects. Provides suitable reports and presentations.
  • Develop and provide training to production personnel during new technology transfer.
  • Support production and customers by resolving issues and problems. Drive continuous improvement, perform root cause analysis and ensure issue resolution is effective.
  • Communicate and coordinate within the Engineering department and with Account Managers, Quality personnel, Materials, and Production to ensure quality of product and services.
  • Leads engineering efforts to resolve issues and provide cross-functional solutions to meet customer needs.
  • Communicates and resolves issues with customers, officials and contractors. Acts as company engineering representative at associated meetings.
  • Perform mechanical design and floor layout in CAD. Leads efforts to implement these designs and facility updates
  • Leads efforts to support our Quality Management System (QMS).
  • Incorporate and apply Lean Manufacturing concepts in all job functions

 

Qualifications:

  • 4-year Bachelor of Science in Engineering or closely related field such as physics.
  • Excellent interpersonal and communication skills, both written and verbal.
  • Broad understanding of electronics manufacturing and processes.
  • Experience with Lean Manufacturing concepts and implementation.
  • Ability to interpret a written or oral instructions and documents furnished in diagrams, CAD files, drawings, and/or other forms.
  • Ability to multi-task and set tasks to maintain a schedule.
  • High Aptitude, level of attention to detail, energy, and good analytical skills.
  • 5+ years of related experience in related manufacturing environment.
  • Develops and leads complex projects, manages project schedules and leads engineering and cross-functional teams.
  • Working knowledge of Word, Excel, and CAD required. Experience with MRP/ERP systems, especially Epicor software, preferred. AEGIS software experience preferred.

 

Posted: May 16, 2018, 1:32 pm
Category : Manufacturing Engineer
Job Type : Permanent
Id : 7364
Region : Twin Cities

Seeking a Continuous Improvement Engineer to be primarily responsible for improving new or existing manufacturing processes to improve quality and reduce lead time, cost, or safety risks. Effectively plans, develops or improves processes through the reduction of waste and change management. Identifies opportunities and implements changes to improve quality of machined parts and/or to reduce costs using knowledge of the machining process. Position works under minimal supervision.

Essential Job Duties & Responsibilities:

  • Obtains and maintains knowledge on all appropriate equipment and processes.
  • Develop, evaluate, and improve manufacturing methods.
  • Value Stream Map production processes to determine optimal material flow and inventory turns
  • Lead change
  • Improves documents, fixtures and tooling, or CNC programs integral to the machining process.
  • Plans and leads continuous improvement projects to meet desired objectives such as Takt Time, Scrap Reduction, or single piece flow.
  • Troubleshoots root causes of machining/materials failures using scientific problem-solving methods and recommends changes in fixture designs, tolerances, tooling, and/or processes.
  • Works with Manufacturing Engineers to develop or improve manufacturing processes for new and legacy products.
  • Works with Quality Engineers to develop quality plans for part manufacturing.
  • Utilizes Statistical Process Control (SPC) to monitor key features and process capabilities.
  • Takes positive corrective action based on Run Charts, defective material or other quality information provided to improve product quality and process reliability.
  • Stays current with latest technological and industry trends to improve our manufacturing environment.
  • Purchases tooling and identifies tooling improvements critical to machining and production process.

Qualifications and Skills Required:

  • Demonstrated knowledge and proven track record of lean manufacturing improvement.
  • Five years of Manufacturing or Process Engineering experience or related experience preferred.
  • Bachelor’s degree in Mechanical or Manufacturing Engineering or related field preferred.
  • At least 5 years of experience in the machining industry (turning and milling steel and aluminum) preferred.
  • Experience with 3D CAD programs, preferably Pro E/SolidWorks.
  • Understanding of machine programming – Macro programming, feature recognition, and Dynamic High-Speed Milling desired.
  • Knowledge and experience creating blue prints and understanding geometric tolerances is required.
  • Working knowledge of Statistical Process Control (SPC) is required.
  • Good verbal and written communication skills.
  • Strong math and mechanical aptitude skills.
  • Working knowledge of Enterprise Resource Planning (ERP) and material flow.


Posted: May 16, 2018, 6:57 am
Category : Controls Engineer
Job Type : Permanent
Id : 7363
Region : Twin Cities

Seeking an Advanced Controls Engineer - Systems Engineer for control system design and application of various technologies. Technologies include multi-axis motion control, image processing, vision-guided robotics, and industrial instrumentation & automatic control. Candidate will have the ability to provide technical direction in a team-oriented work environment, interface with customers on technical projects, design electrical controls, program PC/PLC/motion/vision, and startup/commission machine control systems.

Ideal candidate will have strong electromechanical aptitude, software development experience, and will have experience in the application of motion control, robotics, PLC/PC programming, HMI”s,and/or vision applications to accomplish customer requirements. Familiarity with programming Adept, Allen-Bradley, VB, and/or Cognex/DVT a plus. In addition, solid organizational skills, a demonstrated ability to own and drive projects to completion, along with a strong desire to work in a fast-paced, entrepreneurial environment is required.

Qualified candidate will have a BS or MS in Mechanical or Electrical Engineering, Computer Engineering, or Computer Science with a minimum GPA of 3.0. 2-6 years of relevant experience is highly desired.




Posted: May 16, 2018, 6:50 am
Category : Engineer/Physics
Job Type : Contract-to-Hire
Id : 7360
Region : Twin Cities

Seeking an Optics Engineer to model, design, and test optics components for company products. This position will also generate and update quality documentation such as requirements, test protocols and reports, justifications, and specifications.

Experience:

  • 5 years industry experience, preferably in medical diagnostics
  • M.S. or higher in Photonics, optics design, or related field

Additional Requirements:

  • Optical scatter and fluorescence flow cytometry
  • Imaging
  • Spectrophotometry
  • Hematology
  • Optics modeling and CAD software tools


Posted: May 9, 2018, 7:27 am
Category : Project Manager
Job Type : Permanent
Id : 7356
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. Individual will be responsible for project leadership on build to print and custom automation design and build projects. Project manager will:

  • 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

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.

The 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: May 2, 2018, 9:31 am
Category : Electrical Designer
Job Type : Contract-to-Hire
Id : 7355
Region : Twin Cities

Seeking an AutoCAD Controls Designer to perform the following:

  • Mechanical layouts of control panels
  • Electrical wiring schematics
  • Communication networks drawings
  • Pneumatic diagrams
  • Piping & Instrumentation Drawings
  • Power Drawings
  • MCC layouts and drawings
  • Experience with AutoCAD is required
  • AutoCAD Electrical experience is a plus

 

Posted: May 1, 2018, 6:52 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7354
Region : Twin Cities

Seeking a Senior Engineering Technician for the following duties:

  • Lead E-techs; able to direct, organize, and “own the build process”
  • Assign specific tasks for yourself and other technicians daily
  • Maintain build schedule, working directly with the project manager and designers to overcome obstacles
  • High complexity wiring and mechanical assembly
  • High level troubleshooting and machine “power up” ability
  • Low level I/O checkout, basic end of line mechanical alignments
  • Assist in design suggestions and responsibility for implementation in the build
  • “Ownership” of the print package; Ensure redlines are captured, authorize and/or perform minor modifications
  • Limited field service duties
  • AAS


Posted: April 30, 2018, 1:10 pm
Category : Software Engineer
Job Type : Contract
Id : 7350
Region : Twin Cities

Looking for a LabVIEW Developer to be responsible for designing, implementing, commissioning, and supporting controls, software, and data acquisition systems. This role requires autonomy and individual drive to successfully execute project deliverables, yet also requires collaboration with other engineers.

Requirements:

  • Deliver production-ready software, and reports for the control and data acquisition of wind tunnels, facility control, and engine test systems
  • Design and implement complex software using LabVIEW
  • Deliver high quality engineering service on schedule and within budget
  • Demonstrate effective individual task management while working within an interdisciplinary team environment
  • Interface with various transducers, instrumentation, and peripherals through a variety of interfaces and protocols. Examples of this include load cells, servo valves, thermocouples, PLCs, VFDs, limit switches.
  • Travel to customer sites for design reviews, site surveys, and system commissioning. Travel is both domestic and international
  • Support or perform system assembly, checkout, and site installation

Qualifications/Education:

  • Bachelor’s degree in Engineering
  • 2 to 5 years of relevant experience implementing automation systems using LabVIEW
  • Working knowledge of electronics and electrical systems used in systems test, automation and control applications
  • Working knowledge of instrumentation schematics and system wiring diagrams
  • Working knowledge of electro-mechanical and electro-hydraulic systems
  • Excellent problem solving and troubleshooting capabilities
  • Excellent written and oral communication skills, demonstrated initiative, and attention to completeness, accuracy, and detail
  • Ability to work alone effectively and interface productively with customers, project managers, engineers, and other staff
  • Demonstrated ability to meet budgets and schedules
  • Willingness to travel for business - up to 20%
  • Due to the nature of our work US citizenship or permanent residency is required


Posted: April 27, 2018, 8:20 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7348
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: April 26, 2018, 7:17 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 7345
Region : Twin Cities

The Optical Design Engineer is responsible for the design of custom optical systems for sensors. This includes concept design, detail design, testing, documenting, and transferring the design into production.

Responsibilities:

  • Design of custom precision optical systems for imaging and projection: telecentric, achromatic, low-distortion, etc.
  • Design of various illuminators: dark field, bright field, cloudy day, kohler, etc.
  • Analysis and testing of optical systems to verify optical performance and overall sensor performance
  • Concept design to scope development effort and architect product configuration
  • Risk identification and reduction through feasibility prototypes, analysis, and testing
  • Communicate with customers and end users 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

Requirements:

  • Experience as an optical design engineer, designing custom imaging and illumination lens system
  • M.S. degree in Optical Engineering, or equivalent field with an Optical emphasis
  • 2-8 years of experience designing multi-element optical lens systems
  • Proficient in Zemax OpticsStudio, sequential and non-sequential
  • Experience with optical and system level tolerance analysis
  • Experience with Matlab, Python, or other high leveling programming and analysis packages
  • Experience/knowledge of optical manufacturing processes especially lens grinding, centration, coatings, and optical assemblies
  • Experience with illumination and color calibration
  • Experience in a structured development process from requirements definition, to concept design, to detail design, to testing, and implementation into production
  • Must work well in teams with other Engineering disciplines, including Electrical, Mechanical, Software, and Manufacturing
  • Good interpersonal skills. Good oral and written communications.


Posted: April 24, 2018, 2:40 pm
Category : Firmware Engineer
Job Type : Contract-to-Hire
Id : 7333
Region : Twin Cities

Excellent opportunity for a Senior Embedded Software Engineer / Firmware Engineer for R&D design and development of medical software and instrumentation. Embedded software development is the key responsibility along with test, troubleshooting, and documentation.

 

Qualifications:

  • Experience in a medical product development environment.
  • Software design experience with 8, 16, and 32-bit micro-controllers/microprocessors.
  • Software experience with C in an embedded environment
  • Embedded Linux, QT and RTOS experience

 

Responsibilities:

  • Write software in a microprocessor-based embedded environment.
  • Design and documentation of embedded software for medical products.

 

Education / Experience:

  • BS in Electrical Engineering or Computer Science.
  • Minimum 10+ year's related experience in electronic instrumentation development with particular emphasis on software design. Good oral and written communication skills.


Posted: April 17, 2018, 2:02 pm
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 7332
Region : Twin Cities

Immediate opportunity for a Senior Electrical Engineer for the design and development of medical electronics and firmware. Electronic development is the key responsibility. Ability to write embedded firmware would be a plus. Excellent growth potential for an individual with strong hardware design experience, and who can demonstrate the ability to manage complex projects involving electronics and software.

Qualifications:

  • Experience in a medical product design environment.
  • Electrical design experience with 8, 16, and 32-bit micro-controllers/microprocessors.
  • Analog electrical design experience with an emphasis on biological signals.
  • Electrical design of circuitry for signal acquisition, storage, and processing.
  • Electrical design of circuitry involving servo and stepper motor control.
  • Creation of specifications and test protocols.
  • Firmware experience with C in an embedded environment is a definite plus but not necessarily required.

Responsibilities:

  • Ability to create system/electrical/software requirements for medical product design.
  • Analog and digital design and documentation of electronics for medical products.
  • Design and documentation of embedded software for medical products.
  • Ability to manage a project team.
  • Ability to be the key project contact for customers and maintain project schedules and budgets.

Education / Experience:

  • BSEE degree and minimum 10+ years related experience in electronic instrumentation development with particular emphasis on electrical design.
  • Requires good oral and written communication skills, experience working with vendors and customers, and interest in a quick paced product development environment.


Posted: April 17, 2018, 1:51 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7329
Region : Twin Cities

Seeking a Mechanical Design Engineer to be responsible for the design, development, testing, and production of both new and existing medical devices.

POSITION RESPONSIBILITIES:

  • Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business
  • Verify the functionality of product design by developing design test methodology and specifications in order to ensure product designs meet applicable performance requirements
  • Create project plans, tasks and deliverables in order to manage own time to meet project deadlines
  • Handle troubleshooting and problem solving tasks related to assigned portion of design project.
  • Document and support decisions using engineering analysis and data
  • Interface with vendors, manufacturing facilities and various internal groups to resolve design and manufacturability issues of new and existing products
  • Observe surgery and interface with customers/cardiac surgeons
  • Perform day-to-day job responsibilities in a U.S. and internationally regulated work environment

POSITION QUALIFICATIONS:

  • BS in Mechanical Engineering, BS Biomedical Engineering, or equivalent
  • 0-2 years of medical device engineering experience
  • Ability to work effectively within a multi-functional team environment
  • Provide creative solutions to unstructured problems
  • Familiar with the use of CAD systems (Pro/E, SolidWorks), FEA and DOE analysis
  • Frequent use and application of technical standards, principles, theories, concepts, and techniques to contribute to completion of milestones associated with specific projects

PREFERRED QUALIFICATIONS:

  • MS in Mechanical Engineering, MS Biomed Engineering, or other related engineering discipline
  • 2-4 years of medical device engineering experience
  • An understanding of clinical/technical applications of surgical products and human anatomy


Posted: April 9, 2018, 1:22 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 7327
Region : Twin Cities

Seeking an experienced Inspector to use predetermined methods, operations, setups and prescribed specifications to inspect complex molds, fixtures, gauges, and piece parts to insure that they conform to all dimensional requirements and quality specifications.

POSITION DESCRIPTION:

  • Uses various measuring devices and testing equipment.
  • Accepts, rejects, or reworks defective or malfunctioning units or systems.
  • Works from blueprints, diagrams, dial indicators, preset micrometers, scales, fixtures, tool maker scope, open setup, Ziess coordinate measuring machine or equivalent, customer specifications, drawing or inspection instructions and checklists.
  • May monitor and verify quality in accordance with statistical process or other control procedures.
  • Works under limited supervision, with no instruction needed on routine work and general instructions given on new activities.
  • Thoroughly knows inspection equipment and established operational procedures.
  • Performs a wide variety of non-routine clerical tasks.

POSITION REQUIREMENTS:

  • Requires minimum of 4 years of experience with geometric tolerancing techniques.
  • Vocational training and/or certification in tool room inspection.


Posted: April 6, 2018, 7:14 am
Category : Project Manager
Job Type : Contract
Id : 7326
Region : Twin Cities

Seeking a Program Coordinator to assist the company in the design and maintenance of a program focusing on identifying key technology efforts required to support the innovative product pipelines across the enterprise. This position will provide some project management direction and integration in conjunction with cross-functional teams.

 

Position Responsibilities:

  • Provide input to establishing program objectives, timelines, milestones, and budget
  • Coordinate program working meetings to ensure projects move forward in a timely manner
  • Assist in maintaining effective systems to track project status and report progress against key program deliverables including the creation and maintenance of program dashboards and monitoring tools.

Position Requirements:

  • Requires a University Degree and minimum of 2-3 years relevant experience
  • Experience with Microsoft Office (PowerPoint, Excel, Word)


Posted: April 5, 2018, 6:58 am
Category : Software Test Engineer
Job Type : Permanent
Id : 7320
Region : Twin Cities

Seeking an experienced, high caliber Senior Systems Verification Engineer to join our System Verification team for development projects within the organization. This candidate will bring testing and leadership expertise to the verification of medical device systems. Responsibilities include requirements analysis, test design, test execution, defect issue resolution, project leadership, and support of the engineering team’s investigation of field complaints.

Position Responsibilities:

  • Design test suites for new product features and functionality
  • Lead product testing projects including estimation, planning, coordination, project deliverables, and directing the day to day tasks of others
  • Work independently and as a team member to plan, write, and execute test cases
  • Participate in the requirements, hazard analysis, and design reviews for new features
  • Display initiative, leadership and coaching skills including continuous quality/engineering process improvement, project leadership, and team training
  • Evaluate, recommend, and employ system tests tools to ensure system quality
  • Provide verification and validation perspective to R&D’s ongoing product development, requirements, product and test designs, defect reviews, user workflows, and field complaint investigations
  • Maintain expert status and continuing proficiency in the field of system test engineering

Position Requirements:

  • Bachelor of Science in engineering
  • Minimum of five years of relevant work experience including system-level test development
  • Understanding of hardware-software systems, requirements leveling, and interface requirements
  • Experience working in the medical device industry or other highly regulated industry
  • Demonstrated ability to develop new methods for characterization of system performance and verification of system functionality
  • Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a cross-functional team and as an individual contributor in a fast-paced, changing environment
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Strong organizational and follow-up skills, as well as attention to detail

Preferred Qualifications:

  • Master of Science or equivalent in Systems Engineering, Electrical Engineering, Computer Science, Computer Engineering
  • Current industry knowledge of electrophysiology and/or cardiac rhythm management products
  • Experience with LabVIEW, C++, Perl, and Python programming languages



Posted: April 2, 2018, 1:34 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7319
Region : Twin Cities

Immediate opportunity for an Equipment / Controls Automation Technician to support design, start-up, troubleshooting, and validation of automated equipment for medical device product manufacturing. This position will support Controls Engineers in machine design development, including Autocad Electrical design and documentation of control panels, schematics, and mechanical components, updating / programming PLC and HMI software, support repeat equipment builds, and troubleshooting and solving hardware and software (PLC, HMI, Vision) issues.

Requirements include:

  • 2 year Electrical / Automation Tech degree, with
  • Training and experience in design, programming, and troubleshooting of industrial control systems.
  • Requires proficiency with Autocad Electrical Cad, and training in troubleshooting PLC and HMI systems, robotics, machine vision, and controls instrumentation.
  • Will consider entry level candidate with solid training in automated systems, or technician with up to several years of experience.


Posted: April 2, 2018, 8:52 am
Category : Quality Engineering
Job Type : Contract
Id : 7315
Region : Twin Cities

The Senior Quality Engineer - Pharma will provide quality assurance expertise for the development, site transfer, manufacturing and testing of combination medical device/drug products.

This role will provide quality engineering support in sterilization management, environmental control, and cGMP pharmaceutical manufacturing of combination products including analytical lab activities. Provide support to internal and external customers, perform root cause analysis and implement corrective action. May manage projects for new or revised products or quality system changes in cGMP pharmaceutical requirement of combination products. Provides coaching on cGMP regulations and all relevant standards to Quality and Manufacturing Engineering staff. to staff.

 

POSITION RESPONSIBILITIES:

  • Leads Quality System (QS) development for compliance to drug cGMP manufacturing (FDA 21 CFR Parts 210 & 211)
  • Guides, supports and approves development of facilities, utilities, cleanroom, equipment, production processes and controls, cleaning, inspection and testing and batch records for device and combination product.
  • Provides expertise in all aspects of QA: cGMP, pharmaceutical manufacturing, API handling and controls, clean room environments and environmental controls, sterilization, supply chain quality, contamination control, QC unit responsibilities, etc.
  • Develops training programs as needed in areas such as use of equipment, inspection methods, statistical methods, processes, sterilization, environmental controls, quality system etc. to maintain required level of knowledge in cGMP regulations.
  • Approves validation protocols and reports, including but limited to those associated with drug or combination product manufacture, laboratory activity/analytical methods, cleaning validation, and master validation plans.
  • Approves and conducts supply chain evaluations, audits, and approvals including, but not limited to: sterilization facilities, API manufacturers, processing facilities, analytical labs, controlled environment services, etc.
  • Performs internal quality system audits, including establishing audit plans and writing audit reports, and ensure compliance to drug cGMP manufacturing (FDA 21 CFR Parts 210 & 211)
  • Responsible for annual product reviews of all combinations products manufactured
  • Responsible for managing API, materials and product retains.
  • Leads and/or Support all notified bodies and regulatory audits at the site
  • Performs investigations, determines disposition of returned goods, determines reinspection requirements, determines corrective and preventive actions, issues complaint reports, completes customer corrective and preventative actions (CAPAs)
  • Develops project plans and schedules to lead medium to large size projects with definable objectives and due dates.

 

REQUIREMENTS:

  • Bachelor's degree in Science or Engineering or any relevant technical degree, or equivalent experience.
  • 10 plus years of pharmaceutical or combination product manufacturing industry experience,
  • Comprehensive understanding of drug cGMPs and ICH Q7.
  • Comprehensive understanding of drug GMP facilities, utilities and cleanroom requirements particularly for potent compound APIs.
  • Comprehensive understanding of analytical laboratory testing.
  • Strong written and verbal communication skills in the English language.
  • Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards.
  • Working knowledge of statistical methods associated with six sigma and quality control
  • Effective project leader. & experience with lean manufacturing principles and their implementation.
  • Ability to maintain a professional and respectful relationship with coworkers and company

 

Posted: March 29, 2018, 2:09 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7307
Region : Twin Cities

Seeking a Senior Technician for the following duties:

  • Performs a variety of duties in the electronic, mechanical, electromechanical, and/or optical areas.
  • Constructs, troubleshoots, calibrates, adjusts, tests, diagnoses, and maintains equipment, components, devices, or systems.
  • Works from schematics, engineering drawings and written or verbal instructions.
  • Operates related equipment; conducts tests and reports data in prescribed format. Performs calibration and alignment checks; makes adjustments, modifications, and replacements as directed; prepares prescribed compounds and solutions.
  • Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development.
  • Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems.
  • Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations.
  • Seasoned individual contributor, working under limited supervision, and providing assistance and training to lower level employees.
  • Runs minor projects, including performing tests, interpreting data, developing reports.
  • Requires minimum of 4 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.


Posted: March 22, 2018, 2:43 pm
Category : Electrical Engineer
Job Type : Permanent
Id : 7298
Region : Twin Cities

The Senior Electrical Engineer- R&D will provide design support for new product development teams creating electromechanical products for the medical device industry. Performs specified electrical engineering support activities such as design and test of electrical circuits, motor control devices, sensors, switches and other electrical equipment components.

Primary Duties and Responsibilities:

  • Designs, develops, prototypes, measures, modifies and tests cost-effective electrical systems as part of electromechanical equipment development. Specification and qualification of new electrical designs.
  • Designs, models, implements, and tests electrical circuits for DC brushless motor control.
  • Designs with knowledge of electronics and understands the interdependencies/design constraints with other project team members. Exhibits cooperation and sound judgment in design tradeoffs resulting in reliable designs.
  • Design For: Quality, Reliability, Serviceability, Manufacturability, Test and Product Cost while meeting the needs of the customer.
  • Develop tests for design verification and validation for electromechanical products. Perform design verification activities.
  • Design, build, verify and document manufacturing test fixtures.
  • Simulation of circuits and systems as appropriate to assure product performance.
  • Diagnose the causes of system failures and specify solutions.
  • Develops intellectual property to maintain competitive advantage.
  • Rigorous documentation, including design specifications, verification test plans, project schedules and change orders associated with medical devices.
  • Develops & maintain project plans, coordinates project activities, set/adhere to milestones, manage concurrent projects.
  • Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion.
  • Interface with Operations teams to ensure smooth transfer of products into production.
  • Direct outside contract personnel as needed for completion of specific tasks.
  • Support compliance to Regulatory Requirements including electromagnetic interference/electromagnetic compatibility (EMI/EMC), Underwriters Laboratories (UL), REACH/RoHS and other environmental standards.
  • Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.
  • Ensures product meets requirements regulated by FDA, UL, IEC, CE and other governing bodies.
  • Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications.

Required Skills/Experience:

  • Bachelor of Science in Electrical Engineering
  • 5+ years of electrical engineering experience
  • Hardware development through full product life-cycle
  • Experience with DC brushless motor control design
  • Ability to specify and evaluate electrical components based on performance, lifetime, and availability
  • Experienced in schematic capture and printed circuit board layout using Altium Designer, PADS or equivalent
  • Familiarity with development and debug tools. Demonstrated ability to use a multi-meter, oscilloscope, spectrum analyzer, and logic analyzer
  • Demonstrated project management skills
  • Strong interpersonal and communication skills
  • Strong problem solving skills
  • Excellent technical writing skills
  • MS Office suite, MS Project

Preferred Skills/Experience:

  • 3+ years medical device experience
  • Familiarity with embedded systems, microprocessors, and communication protocols
  • Understanding of EMI and UL requirements.
  • Experienced in the design of experiments, data analysis, statistical methods and presentation of results.


Posted: March 21, 2018, 7:01 am
Category : Controls Engineer
Job Type : Contract
Id : 7297
Region : Twin Cities

 

Seeking a Machine Vision Software Engineer / Electrical Engineer / Software Engineer needed 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.

 

Requirements:

  • Bachelor of Science (CS or EE)
  • Manager is open to all levels of experience with automated equipment development, including some hands-on vision system knowledge.
  • Prefer experience with .NET and C++ programming, Allen Bradley PLC's and understanding of automated equipment design.
  • Prefer experience with 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 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 and hardware 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: March 15, 2018, 12:25 pm
Category : Mechanical Designer
Job Type : Contract-to-Hire
Id : 7289
Region : Twin Cities

Looking for a Principal Designer to be responsible for performing conceptual design work for new products as well as proposing improvements to existing components. Works independently and creatively to solve problems and create solutions for tasks assigned. Works closely with engineering to accurately assess the performance of proposed concepts and designs. Works directly with customers and medical advisors to develop new products. Works with suppliers to ensure the products manufacturability, and to develop robust methods of inspection.

Essential Duties and Responsibilities:

  • Create designs for new devices, or improvements to existing products from rough sketches, written or verbal design input specifications.
  • Communicate design status and requirements to engineering and program management.
  • Contribute to identifying engineering requirements. Ensure feasibility and performance is assessed by leveraging engineering resources.
  • Participate in design related discussions with a range of internal and external customers, including medical advisors.
  • Specify and analyze tolerances and fits to ensure safe and effective function of devices.
  • Create solid models, drawings and assemblies that comply with applicable standards.
  • Work with suppliers and Quality Assurance to develop measurement techniques that are accurate and repeatable.
  • Propose and evaluate design changes to existing products.
  • Create and process change orders.
  • Manage prototyping and debugging efforts.
  • Contribute to design and project review meetings.
  • Supports Company’s corporative initiative for Continuous Improvement “FOCUS” by promoting the relentless pursuit of eliminating waste, participating in process improvement, and showing the courage to take action and advocate change.
  • Observes safety and security procedures, including maintaining confidentially, using equipment / materials properly, reporting potentially unsafe conditions, and acting upon appropriate actions.
  • Supports Company’s policies and procedures and conducts departmental and Company activities in accordance with these policies.
  • To perform the job successfully, an individual should demonstrate the following competencies: Adaptability, Cooperation, Dependability, Customer Service, Effective Communication, Problem Solving

Minimum Qualifications

  • Associate's degree (A. A.) or equivalent from two-year college or technical school.
  • Eight to ten years’ experience with implantable medical devices, solid modeling, and drafting.
  • Must be familiar with molding plastic components, CNC machining techniques, rapid prototyping methods and measurement of components.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to write speeches and articles for publication that conform to prescribed style and format.
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Must be an expert in CAD skills for creating solid models, dimensioning and tolerancing of drawings to ensure proper fit and fabrication.


Posted: March 1, 2018, 12:50 pm
Category : Mechanical Engineer
Job Type : Contract-to-Hire
Id : 7288
Region : Twin Cities

Looking for a Mechanical Engineer to design medical devices to comply with industry methodologies and standards. This candidate will define requirements, technologies, and methodologies for individual projects. Research and analyze data such as experimental data, customer design proposals, specifications, and documentation. Direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications. Resolve technical issues and problems. Effectively communicate their work and status. Delegate work and leverage engineering technicians and designers.

Essential Duties and Responsibilities

  • Applies principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
  • Designs medical products and confirms correctness using methodologies and tools such as FEA, GD&T, CFD, etc.
  • Evaluates mechanical and electromechanical systems and products by designing and conducting research programs.
  • Leads and completes medical standard document deliverables.
  • Identifies and efficiently resolves technical problems and issues.
  • Leads and communicates to a client for small scale programs.
  • Researches and analyzes experimental data to understand design issues and set a direction for issue resolution.
  • Prepares product reports by collecting, analyzing, and summarizing information and trends.
  • Delegates and sets work direction for technicians and designers.
  • Works with suppliers and manufacturing facilities to design for manufacturability.

Education/Experience:

  • Bachelor's degree in Mechanical Engineering or equivalent
  • Minimum 3+ years of experience in new product development.
  • Direct experience with the product development process ranging from requirements development, prototyping, verification and product release is required.
  • Experience in medical device design or other regulated industries preferred.
  • Must have demonstrated experience working on electromechanical systems.
  • Prefer experience with IEC 60601-1 and with ISO 14971 Risk Management for Medical Devices.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.


Posted: March 1, 2018, 12:34 pm
Category : Systems Engineer
Job Type : Contract
Id : 7287
Region : Twin Cities

Seeking a Systems Test Engineer who has a strong background in systems engineering and are passionate about system maturity/reliability, integration, characterization, verification, and validation.

 

Position Responsibilities:

  • Work with peer systems engineer(s) during development of user needs, intended uses, and design input requirements to ensure they are validate-able and verifiable respectively.
  • Authors a system level Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage.
  • Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan.
  • Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts.
  • Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers in various functional departments to achieve results.
  • Authors design verification and design validation protocols and reports. Executes system verification and validation activities.
  • Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study.
  • Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study.
  • Plan and execute Test Method and Non-product software validation, and equipment and tooling qualification, per project needs.
  • Monitors progress of assigned tasks to defined project schedule.
  • Produce high quality deliverables while complying with relevant SOP.
  • Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval.

 

Basic Qualifications:

  • 2+ years of job-related experience with a Bachelor's or Master's degree.

 

Desired/Preferred Qualifications:

  • Bachelor's or Master's Degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, Reliability Engineering, or Mathematics.
  • Experience in engineering and testing mission critical systems and/or medical device systems.
  • Demonstrated experience maturing System with significant electrical component.
  • Experience working with detailed requirements and traceability in order to author test plans, protocols, and reports.
  • Experience working in cross-functional team effort.
  • Demonstrated strong verbal/written communication and influence management skills.
  • Proven ability to accomplish critical project level objectives in a team environment.
  • Knowledge of or experience working with Systems Engineering principles.
  • Knowledge of or experience working in a regulated and/or FDA medical device environment.
  • Knowledge of or experience working with ISO and Quality System Regulation requirements.


Posted: March 1, 2018, 6:30 am
Category : Electrical Power & Lighting
Job Type : Permanent
Id : 7122
Region : Twin Cities

Qualifications / Requirements:

  • BSEE with a minimum 5 years of engineering design experience
  • Must have a Minnesota PE in electrical engineering
  • Specify and design the installation of medium voltage, relaying, low voltage switchgear and motor control equipment
  • Must have a minimum 2 years’ experience in power system engineering analysis using SKM software
  • Good working knowledge of the current National Electrical Code
  • Capable of producing and supervising the production of industrial electrical construction drawings, specifications, and other documents
  • Proven communication skills and the ability to supervise project teams are required along with the ability to work closely with clients and teams from other disciplines
  • Ability to travel from time to time as needed

Responsibilities:

  • Apply the company’s engineering principle to complete engineering designs associated with the capital projects
  • Technical and execution activities will be performed including system studies, specifying hardware, calculations, preparing and performing project estimates, scheduled, effort-hours, and material forecasts to ensure consistency with engineering standards and operating principles.
  • Perform plant Short-Circuit, LV/MV Coordination and Arc Flash studies using the SKM power tools software.
  • Lead the marketing of power system engineering analysis efforts to internal / external clients
  • Supervision of project teams will be required


Posted: October 25, 2017, 8:06 am
Category : Controls Engineer
Job Type : Contract
Id : 7100
Region : Twin Cities

Excellent opportunity for 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.

 

2-5 years of experience in automated system design, and will consider junior level candidates with control system training and some hands on automation experience.

 

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). 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: September 25, 2017, 8:16 am