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Development Resource Group

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

Category : Software Test Engineer
Job Type : Contract
Id : 7881
Region : Twin Cities

We are seeking high caliber Software Verification Engineer to bring testing expertise to our innovative and fast-paced Software Verification team. This motivated and passionate individual will be responsible for requirements analysis, test design, test execution, defect issue resolution.

Responsibilities include:

  • Work independently and as a team member to plan, write, and execute test cases according to FDA regulatory, and ISO standard procedures.
  • Design new test suites for new features and functionality.
  • Perform dry runs and formal Verification activities as required.
  • Setup and configure Test Equipment.
  • Record and close defects found during V&V activities.
  • Perform requirements, design and tests reviews.

Experience and Education Required:

  • Bachelor’s degree in Computer Science, Computer, Electrical or Biomedical Engineering.
  • Knowledge of software testing.
  • Knowledge of software development lifecycle management tools.
  • Organized, on-time, quick learner and detailed oriented.
  • Excellent documentation skills in delivering information that adds value to management’s decision-making process.
  • Experienced in quantitative, analytical, organizational, and follow-up skills.
  • Polished communicator - written documentation and oral presentations/ discussions/ meetings.
  • Excellent reputation for building relationships across various levels of an organization.
  • Energized attitude, proactive thinker and self-starter.


Posted: March 31, 2020, 8:58 am
Category : R&D Engineer
Job Type : Contract
Id : 7880
Region : Wisconsin

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

Position Responsibilities:

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

Position Requirements:

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


Posted: March 30, 2020, 7:15 am
Category : Quality Engineering
Job Type : Contract
Id : 7879
Region : Twin Cities

Seeking a Quality Engineer to evaluate, support, and troubleshoot a manufacturing line.

  • Evaluation of production equipment
  • Production support and process validation
  • Troubleshoot manufacturing process and equipment
  • Protocol and report writing
  • Generate and modify manufacturing process documentation
  • Work with cross functional teams as required
  • Develop and implement process improvements


Posted: March 30, 2020, 7:09 am
Category : Electrical Engineer
Job Type : Contract
Id : 7878
Region : Twin Cities

The Senior Electrical Engineer performs the layout, construction, and evaluation of a variety of prototype Printed Circuit Boards, fixtures, and tools. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing and coordinating of engineering work. Performs technical studies.  Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.

 

PRIMARY RESPONSIBILITIES:

  • Leads and/or participates on engineering teams in completing development projects.
  • Completes system, analog, digital, and firmware designs.  This includes setting and revising requirements and specifications, debugging, testing electrical circuits and systems, and completing documentation to ensure feasibility and verifiability of 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.
  • Identifies and mitigates project risks.
  • Conceptualizes improved designs using technical expertise and innovative approaches.
  • Interfaces with various internal functions, outside consultants, vendors.
  • Establishes test methods
  • Ensures compliance with procedural and documentation requirements of FDA and ISO design controls
  • Supports and leads design reviews
  • Solves complex and diverse technical problems by applying sound judgment, creativity, appropriate data analysis, and technical expertise.

 

REQUIRED QUALIFICATIONS:

  • Bachelor's degree in Electrical Engineering
  • Analog and digital design experience
  • PCB design, preferably with Altium
  • Experience with high voltage and high frequency design
  • 7+ years of experience in medical device development
  • Strong verbal and written communication skills

 

PREFERRED QUALIFICATIONS:

  • Master's and/or PhD degree in Electrical Engineering
  • Embedded firmware design
  • Design simulation
  • FPGA/VHDL design
  • Previous experience in cardiac electrophysiology and/or cardiac rhythm management
  • Familiarity with IEC 60601, ISO 13485 and 21 CFR 820.30 family of standards


Posted: March 30, 2020, 6:57 am
Category : Packaging Engineer
Job Type : Contract
Id : 7877
Region : Twin Cities

Seeking a Packaging Engineer to be responsible for providing package engineering support in the creation, development and improvement for medical device packaging systems (invasive and non-invasive).

Position Responsibilities:

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures
  • Researches, develops, designs, evaluates and documents packaging systems, materials, incoming receiving, distribution systems and packaging line equipment
  • Develops new concepts from initial design to market release
  • Directs support personnel, coordinates, and reports on project activities
  • Write and submit intellectual property (patents, when applicable)
  • Investigates and evaluates existing technologies for potential improvement or use
  • Reviews or coordinates vendor activities to support development and use.

Requirements:

  • Bachelor's degree
  • Advanced degree preferred.


Posted: March 25, 2020, 9:17 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7876
Region : Twin Cities

We are seeking a high caliber, motivated, self-driven Manufacturing Engineer to join our manufacturing engineering team. Individual in this role will support the operations team as a front-line engineer working with assemblers and troubleshooting equipment and process issues. Additionally, this position will manage projects aimed towards designing and developing manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality. This individual will have a unique opportunity to make a mark on the organization as a leader, while working on state-of-the-art product. This individual will be able to make a significant P&L impact in the organization. 

 

Job Duties:

  • Front line engineer supporting operations team
  • Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions.  Provide guidance to other engineers and technicians.  Additional responsibilities include:
  • Provide technical mentorship to engineers and technicians
  • Conduct Process FMEAs and Process Validations
  • Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concept
  • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment
  • Work with Product Development to ensure Design for Manufacturability
  • Be innovative, resourceful, and work with minimal direction
  • Have excellent organization, problem solving, communication, and team leadership skills
  • Work effectively with cross-functional teams   
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

 

General Qualifications:

  • Mechanical, Chemical, Biomedical or any engineering or technical degree or equivalent experience required
  • 3+ years manufacturing engineering experience
  • Medical device experience preferred, but not required
  • Strong analytical, problem solving and project management skills
  • Demonstrated leadership capability in team setting
  • Ability to lead and motivate peers, drive change and problem solve with creativity
  • 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.
  • Results oriented, Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 10%, including internationally.
  • Ability to maintain regular and predictable attendance.


Posted: March 25, 2020, 7:38 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7875
Region : Twin Cities

We're looking for a Senior Continuous Improvement Engineer to work closely with the cross functional Value Stream teams. This position will design, develop, standardize and implement Operational Excellence methods intended to continuously improve manufacturing system performance. This individual is an influencer and facilitator, with a track record of managing change, and is a systems thinker who solves problems by building relationships and collaborating.

Impact this role will have:

  • Participates in identification and planning of department goals and budget, development, standardization and implementation of initiatives intended to improve the quality, cost and delivery performance.
  • In conjunction with the Value Stream teams, supports productivity, quality, process efficiency, space utilization, standardization and lead time improvement efforts.
  • In collaboration with the Continuous Improvement Department, supports Lean, Six Sigma and DMAIC problem solving initiatives.
  • Identifies opportunities and drives incorporation of appropriate Lean tool usage such as 5S, time study, line balancing, standard work, material flow and value stream mapping into the daily functions of the Value Stream teams.
  • Collaborates with cross functional teams as required.
  • Provides input into departmental budgeting processes as required.
  • May supervise and provide work direction to other engineers and technicians.
  • Understands work environment issues (i.e. OSHA regulations, etc.).
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Experience, education and knowledge:

  • BS in Industrial Engineering or related field or equivalent experience; advanced degree preferred.
  • 5+ years manufacturing engineering experience.
  • Medical device experience preferred.
  • Strong analytical, problem solving and project management skills.
  • Demonstrated leadership capability in team settings.
  • Six Sigma or Lean Certification 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 15-30%, including internationally.


Posted: March 25, 2020, 7:26 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7874
Region : Twin Cities

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

Requirements:

Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering.

Minimum of 6 years of experience in an engineering discipline or advanced education.



Posted: March 24, 2020, 9:36 am
Category : Systems Engineer
Job Type : Contract
Id : 7872
Region : Twin Cities

Seeking a Senior Systems Engineer to work with a systems integration and test team to perform integration planning, coordination, and testing of a new cloud based platform which provides the users with a web based interface to retrieve and store information from a Medical Device. The Platform includes both mobile applications and servers to combine data sets into a usable format. This individual will join a team to deliver a high quality product to the market on time and on budget.

POSITION RESPONSIBILITIES: Systems Engineer for integration, characterization and verification of a full end-to-end system. Will work as part of a team to ensure full system coverage of testing.

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

POSITION REQUIREMENTS:

  • Must have a bachelor’s degree and 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: March 24, 2020, 7:47 am
Category : Electrical Engineer
Job Type : Contract
Id : 7871
Region : Twin Cities

Seeking an Electrical Engineer to assist in both development and sustaining engineering projects for a major medical device manufacturer.

Position Requirements/Responsibilities:

  • Participates on engineering teams in completing development projects.
  • Leads small-scale design change efforts in support of continuation engineering activities.
  • Completes system, analog, digital, and firmware designs. This includes setting and revising requirements and specifications, debugging, testing electrical circuits and systems, and completing documentation to ensure feasibility and verifiability of performance.
  • Education: Bachelor's degree in Electrical Engineering is required.
  • Years of Experience: 3-10



Posted: March 23, 2020, 12:27 pm
Category : Manager
Job Type : Contract-to-Hire
Id : 7868
Region : Twin Cities

The Electrical Engineering Manager is responsible for leading and supervising a team of highly skilled electrical engineers and technicians as they provide technical solutions to address our customers challenging medical device development programs. These programs include complex electromechanical systems from mobile health devices to implantables.

 

Essential Duties and Responsibilities:

  • Perform lead engineering role as sole engineer or as part of a team
  • Recruit and maintain staff; Resources projects with employees, independent contractors, and temporary contractors.
  • Mentors/coaches staff; Develops and leads staff to establish and maintain excellence in technical expertise.
  • Sets work direction and oversees engineering work.
  • Assists with overcoming roadblocks.
  • Works hand in hand with staff, Program Managers and customers to ensure optimal and sound engineering solutions are implemented within budget and schedule
  • Keep abreast of regulations, standards and provide training to staff and others .
  • Responsible for identification, purchase, training, and maintenance of tools and equipment.
  • Support internal groups across the organization.
  • Establishes and maintains processes/procedures. Ensures policies and process is followed. Effectively creates and supports process enhancement initiatives.
  • Proactively seeks and consistently embodies corporate mission & core values; inspiring & demonstrating motivated behaviors of respect, being Customer-Focused & Committed to Success, providing Great Communication & a Sense of Urgency.
  • Supports corporative initiative for Continuous Improvement "FOCUS" by promoting the relentless pursuit of eliminating waste, participating in process improvement, and showing the courage to act 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 corporate policies and procedures and conducts departmental and Company activities in accordance with these policies.

 

Core Competencies:

  • Achievement Focus - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; recognizes and acts on opportunities; takes calculated risks to accomplish goals.
  • Communications - Expresses ideas and thoughts verbally; expresses ideas and thoughts in written form; exhibits good listening and comprehension; keeps others adequately informed; selects and uses appropriate communication methods.
  • Managing Customer Focus - Promotes customer focus; establishes customer service standards; provides training in customer service delivery; monitors customer satisfaction; develops new approaches to meeting customer needs.
  • Managing People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; makes self-available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services; continually works to improve supervisory skills.
  • Planning and Organization - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
  • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
  • Supervisory - Directly supervises employees.  Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

Education/Experience:

  • Bachelor's of Science degree in science related field
  • Minimum of 7+ years of experience with demonstrated success in Medical Product Development Minimum 3 years in a leadership role. 
  • Knowledge of medical device Regulations (examples: 21 CFR, ISO 13485, ISO 14971, ISO 9001, etc.).
  • Comprehensive knowledge of electrical engineering in a regulated field is a must.

 

Posted: March 23, 2020, 5:46 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7866
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: March 10, 2020, 2:11 pm
Category : Software Engineer
Job Type : Contract
Id : 7865
Region : Twin Cities

Seeking a Senior Software Reliability Engineer who will provide software design assurance engineering support to new product development and sustaining activities, which includes evaluating and driving improvements in the design, reliability and safety to ensure these are proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. This role will also be expected to flex into the released-product space, with responsibility for product performance monitoring, issue management, and continuation engineering support.

A Day in the Life

  • Coordination and guidance to cross functional teams to define software product requirements driven by system safety and performance objectives, develop strategy for achieving the defined objectives, and ensuring the objectives are met
  • Apply system thinking in planning and executing design for reliability and design assurance methodologies and risk management for products or systems.
  • Performs and facilitates risk management, software risk analysis, fault tree analysis, failure trending and failure analysis. Completes risk assessments, including Hazard Analysis (HAs), to evaluate impact of potential issues to patient safety and product performance
  • Provide input to design/process development, design controls, test method development, and design validation for achieving required levels of product safety and performance.
  • Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Serve as a Design Quality Assurance reviewer/approver on design control documents, specifically those associated with product testing and characterization
  • Represent the organization as technical contact for reliability, design assurance, and/or safety and other technical projects and/or programs; create documentation in compliance with applicable procedures to meet project deliverables

General Reliability Engineer responsibilities:

  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data.
  • Must Have-Minimum Requirements: please ensure the minimum requirements are evident on your resume.
  • Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality
  • Master’s Degree Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
  • Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationship
  • Demonstrated engagement and understanding of software development projects
  • Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude
  • Strong attention to detail and accuracy
  • Excellent organization skills; ability to successfully balance and prioritize multiple ongoing projects/tasks
  • Strong analytical skills and the ability to solve problems through analytical reasoning.
  • Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.
  • Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience), including presentation skills
  • High degree of initiative and self-motivation
  • Proficient in word processing, spreadsheets, and managing electronic data files

Nice to Have: Preferred Requirements

  • Experience in medical devices or other highly regulated industry
  • Experience in quality, reliability, design assurance, safety, or systems engineering
  • Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.), 62304 (medical device SW), and 82304 (health care SW)
  • Design for Reliability and Manufacturability (DRM) certification
  • ASQ Certification in Quality or Reliability
  • Knowledge of therapy (clinical) performance, product function(s), and product use environments
  • Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, validation, and prediction
  • Experience with Software Reliability Engineering models including growth models
  • Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications
  • Experience in software development
  • Soft-skills on various scripting tools and macros
  • Experience working on projects using Agile SW development
  • Knowledge/experience working with CAPAs, non-conformances, and other post-market issue escalation
  • Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
  • Strong statistics background


Posted: March 10, 2020, 6:49 am
Category : Reliability Engineer
Job Type : Contract
Id : 7864
Region : Twin Cities

Seeking a Senior Reliability Engineer who will be responsible for the coordination and guidance to cross functional teams to define product requirements driven by system safety and performance objectives, develop strategy for achieving the defined objectives, and ensuring the objectives are met

POSITION RESPONSIBILITIES:

  • Apply systems thinking in planning and executing design for reliability and design assurance methodologies and risk management for products or systems.
  • Performs and facilitates risk management, risk analysis, fault tree analysis, failure trending and failure analysis. Completes risk assessments, including Hazard Analysis (HAs), to evaluate impact of potential issues to patient safety and product performance
  • Provide input to design/process development, design controls, test method development, and design validation for achieving required levels of product safety and performance.
  • Conduct evaluation of new product development activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Serve as a Design Quality Assurance reviewer/approver on design control documents, specifically those associated with product testing and characterization
  • Represent the organization as technical contact for reliability, design assurance, and/or safety and other technical projects and/or programs; create documentation in compliance with applicable procedures to meet project deliverables.

POSITION REQUIREMENTS:

  • Bachelor’s degree in engineering, science or technical discipline and a minimum of 4 years of relevant experience, or Master’s degree with a minimum of 2 years of relevant experience, or Doctorate degree with 0 years of experience
  • Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships
  • Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude
  • Strong attention to detail and accuracy
  • Excellent organization skills; ability to successfully balance and prioritize multiple ongoing projects/tasks
  • Strong analytical skills and the ability to solve problems through analytical reasoning.
  • Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.
  • Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience), including presentation skills
  • High degree of initiative and self-motivation
  • Proficient in word processing, spreadsheets, and managing electronic data files

Nice to Have

  • Experience in medical devices or other highly regulated industry
  • Experience in quality, reliability, design assurance, safety, or systems engineering
  • Experience with and knowledge of medical device standards including ISO 13485, ISO 14971 (risk mgmt.), 62304 (medical device SW), and 82304 (health care SW)
  • Design for Reliability and Manufacturability (DRM) certification
  • ASQ Certification in Quality or Reliability
  • Knowledge of therapy (clinical) performance, product function(s), and product use environments
  • Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, validation, and prediction
  • Experience with Software Reliability Engineering models including growth models
  • Experience in the design, maintenance, or continuation engineering of software or software systems, including mobile applications
  • Experience in software development
  • Experience working on projects using Agile SW development
  • Knowledge/experience working with CAPAs, non-conformances, and other post-market issue escalation
  • Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
  • Strong statistics background


Posted: March 10, 2020, 6:39 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7863
Region : Twin Cities

Seeking a Quality Engineer to identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements

  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Design and conduct experiments for process optimization and/or improvement
  • Appropriately document experiment plans and results, including protocol writing and reports
  • Lead process control and monitoring of CTQ parameters and specifications
  • Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
  • Lead the investigation, resolution and prevention of product and process nonconformances
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Lead in the completion and maintenance of risk analysis
  • Work with design engineering in the completion of product verification and validation
  • Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Experience/Background

  • 2-5 years of experience.
  • Engineering experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
  • Solid communication and interpersonal skills.
  • Project management and leadership skills, including the demonstrated 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.
  • Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing).
  • ASQ CQE or other certifications preferred.

Education

  • Bachelor’s Degree Engineering or Technical Field


Posted: March 5, 2020, 1:52 pm
Category : Industrial Engineer
Job Type : Contract
Id : 7861
Region : Twin Cities

Looking for a Senior Industrial Controls Engineer to design, deliver, and support equipment solutions for a wide range of innovative medical electronics-based products and process control equipment. This candidate will be responsible for the development and release of equipment solutions supporting the release of new product manufacturing lines. This engineer would also be involved in determining if existing equipment is adequate to support production manufacturing requirements for new products. This position would be responsible for designing and implementing both the software and the hardware portion of the equipment solution. This development is accomplished by interfacing with manufacturing and process development engineers to create a compliant solution for production equipment release and support. The equipment solution development includes integration of software and hardware and will include debugging while interfacing to the equipment; perform R&R (repeatability & reproducibility) analyses; qualification and validation documentation, and support for system releases. Utilizes software languages and environments including PLC Ladder Logic, LabVIEW, and/or structured text for the development and writing of code. Troubleshoots software and hardware problems using root cause analysis and provides technical solutions for equipment-related problems and provides yield improvement solutions.

POSITION RESPONSIBILITIES:

  • Developing software applications using Automated Equipment to manufacture or test electronic components utilizing software languages and environments preferably in PLC Ladder Logic, LabVIEW, and/or structured text to perform application software development and electronics design
  • Designing, developing, and debugging dedicated hardware and software, performing verification and validation activities, performing Measurement Systems Analysis (Gage R&R studies); all in support of equipment solution release for production manufacturing of electronic medical device components
  • Deployment and qualification and of equipment. Ensures appropriate documentation is maintained and completed for all technology programs transferred to product line specific areas
  • Design and qualify new custom tooling/equipment (IQ/OQ/PQ, Support)
  • Troubleshooting yield and performance issues to root cause using statistics-based analyses and providing related technical solutions
  • Following software application development procedures and demonstrate compliance through technical documentation generation
  • Active and key participant in the evaluation and strategic planning for new: technology, products and materials and their impact on the business. Performs research and evaluates new ideas & technologies
  • Responsible for department budget as related to Annual Operating Plan targets.
  • Develops electromechanical technical solutions to complex problems that require the regular use of ingenuity and creativity
  • Lead and foster a culture of driving toward high quality designs, collaboration, and innovation
  • Mentors and serves as a both a people and technical leader
  • Work is performed with minimal direction
  • All activities must be performed in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations

EDUCATION/EXPERIENCE REQUIRED:

  • Bachelors in Electrical Engineering, Controls Engineering, Industrial Engineering, Computer Engineering or related Engineering discipline
  • 5+ years of experience in Engineering Design and Development with Bachelors OR 3+ years of experience in Engineering Design and Development with an Advanced degree

SPECIALIZED KNOWLEDGE REQUIRED

  • Software application development experience
  • PLC Ladder Logic, Structured text, Industrial Controls Software, HMI development experience
  • 3+ years of experience working in a medical or other regulated industry
  • Strong communication, manufacturing process, product industrialization and leadership skills
  • Solid design, troubleshooting and presentation skills


Posted: March 5, 2020, 6:22 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7860
Region : Twin Cities

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

Responsibilities:

  • Establish processes based on product and print requirements.
  • Evaluate process and design alternatives based on Design for Manufacturability principles.
  • Production support - Responsible for providing technical support for processes and equipment to manufacturing to ensure high quality and yield
  • Process Optimization – Technical Reports and Test Method Validations
  • Process Validation - Protocol and report writing, as well as execution of IQ/OQ/PQs, and PPQs
  • Root cause analysis and troubleshooting, resolves and/or facilitates the resolution of problems including identifying causes and implementing solutions to prevent re-occurrence.
  • Lead and interact with functional groups (e.g. research and development, quality, manufacturing, supply chain) as necessary to define work breakdown to achieve project goals related to schedule, performance, and cost.
  • Manage program compliance with internal and external standards (e.g. Design Control, Process Validation, and Process Control Plans)
  • Understand work environment issues (e.g. OSHA regulations, etc.)

Experience and Education:

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

Preferred Qualifications:

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


Posted: March 2, 2020, 2:36 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 7859
Region : Twin Cities

Seeking a Senior Materials Engineer to support product and materials development for new and released medical device product, ensuring product safety and reliability through the direction and execution of characterization testing. This will include providing problem solving, materials laboratory testing and data analysis in support of new and existing implantable biomedical devices and systems. Biocompatibility and biostability testing, as well as documenting product equivalence through appropriate characterization testing will also be included.

Additional responsibilities may include providing materials engineering support to document product compliance with international biocompatibility and hazardous substances standards, supporting regulatory submission. Primary areas of focus include testing for and documenting compliance relating to REACH, RoHS, ISO 10993-1 and other regional standards for medical devices. This includes interpretation of standards, interfacing with suppliers for supporting documentation and directing applicable testing to address gaps when necessary.

This person will work under general supervision, solving technical problems with an emphasis on polymer materials, materials analysis, testing and microscopy

 

POSITION RESPONSIBILITIES

  • Conduct laboratory testing and write technical reports to document device/component compliance with necessary regulations and materials characterization requirements.
  • Work in a regulated environment.
  • Support regulatory submissions with technical rationales/documentation on an as needed basis.
  • Guide product development and remediation through the familiarity of international device regulations pertaining to medical devices and Materials of Concern, including RoHS and the European Union Medical Device Directive
  • Communicate results and strategies via detailed technical documents and presentations.
  • Support the quality and reliability of released product through comparative testing or root cause characterization testing.
  • Participate in the analysis of technical issues and the development of recommendations for project decisions and actions

 

POSITION REQUIREMENTS

  • Bachelor's degree in materials, chemical, biomedical, biology or mechanical engineering
  • 5+ years of experience, can be adjusted for candidates with advanced degrees.
  • Materials Science knowledge with an emphasis on polymer materials testing, processing and analysis.
  • Knowledge of international standards, testing and regulatory requirements.
  • Knowledge of Microsoft applications (Excel, Word, Outlook).
  • Experience in a regulated environment.

 

DESIRED QUALIFICATIONS

  • Experience interfacing with suppliers to document regulatory compliance.
  • Experience in polymer characterization techniques including FTIR, DMA, DSC, TGA and chemical degradation tests.
  • Regional experience in medical devices and regulations such as European Union.
  • Experience developing a medical device, including materials characterization, biocompatibility and biostability.
  • Problem solving skills to identify root cause of materials related issues and ability to recommend mitigation strategies.
  • Experience in regulatory and device regulations for medical devices including biocompatibility and regulated materials

 

Posted: March 2, 2020, 7:04 am
Category : BioMedical Engineer
Job Type : Contract
Id : 7858
Region : Twin Cities

Seeking a Senior Biomedical Engineer to support product and materials development for new and released medical device product, ensuring product safety and reliability through the direction and execution of characterization testing. This will include providing problem solving, materials laboratory testing and data analysis in support of new and existing implantable biomedical devices and systems. Biocompabitility and biostabiltiy testing, as well as documenting product equivalence through appropriate characterization testing will also be included.

Additional responsibilities may include providing materials engineering support to document product compliance with international biocompatibility and hazardous substances standards, supporting regulatory submission. Primary areas of focus include testing for and documenting compliance relating to REACH, RoHS, ISO 10993-1 and other regional standards for medical devices. This includes interpretation of standards, interfacing with suppliers for supporting documentation and directing applicable testing to address gaps when necessary.

This person will work under general supervision, solving technical problems with an emphasis on polymer materials, materials analysis, testing and microscopy

POSITION RESPONSIBILITIES

  • Conduct laboratory testing and write technical reports to document device/component compliance with necessary regulations and materials characterization requirements.
  • Work in a regulated environment.
  • Support regulatory submissions with technical rationales/documentation on an as needed basis.
  • Guide product development and remediation through the familiarity of international device regulations pertaining to medical devices and Materials of Concern, including RoHS and the European Union Medical Device Directive
  • Communicate results and strategies via detailed technical documents and presentations.
  • Support the quality and reliability of released product through comparative testing or root cause characterization testing.
  • Participate in the analysis of technical issues and the development of recommendations for project decisions and actions

EDUCATION

  • Bachelor's degree in materials, chemical, biomedical, biology or mechanical engineering
  • 5+ years of experience, can be adjusted for candidates with advanced degrees.


Posted: March 2, 2020, 6:48 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7856
Region : Twin Cities

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

 

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

 

Preferred Skills:

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

 

Posted: February 28, 2020, 1:47 pm
Category : Mechanical Designer
Job Type : Contract
Id : 7854
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer to provide design continuation engineering support for Implantable Medical Device products including Instruments. Projects require the ability to lead and support design changes that are primarily mechanical in nature. Engineering support may be independent or under the direction of a 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 must work effectively with Manufacturing, Supply Management, Quality, Reliability, and Regulatory functions to successfully implement design changes. 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.
  • Good written and oral communication skills
  • Ability to effectively lead projects or project elements in a cross functional team environment
  • Effective teaming skills
  • Strong presentation skills
  • Strong technical writings skills.
  • Understanding manufacturing processes and quality systems is beneficial
  • 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: February 27, 2020, 6:25 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7853
Region : Twin Cities

We are seeking an experienced, high caliber Manufacturing Engineer II. This position will provide technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. The role will be responsible for selecting techniques to solve problems and make sound process design recommendations.

Position Responsibilities:

  • Establishes processes based on product specifications.
  • Evaluates process and design alternatives based on “design for manufacturability” principles.
  • Understands principles of “Cost of Goods Sold”.
  • Maintains knowledge of new developments in manufacturing and design technologies.
  • Understand work environment issues (i.e. OSHA regulations, etc.).
  • 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.
  • Design, document and Provide manufacturing processes, tooling, and fixtures.
  • Evaluation of production inspection equipment, tooling inspection and inspection methods
  • Demonstrated ability to Program CMM equipment in PC DMIS
  • GD&T methodology and understanding
  • Understand PLC programs and Inspection software such as QC Calc
  • Utilize tools like Gage R&R, Cp, Cpk, Bias studies and SPC to improve processes
  • Exposure to Optical inspection and Profilometry equipment
  • Ability to use Solid works or other CAD systems.
  • Modify manufacturing process documentation, MPs & IPs – as needed
  • Provide technical direction to Machinists/ process personal/maintenance technicians
  • Efficiently utilize PDM tools for Machine and tool drawings

Position Requirements:

  • BS degree in Engineering
  • 2 – 4 years engineering experience
  • Experience with inspecting machined medical device components required
  • PC-DMIS Programming and Optical inspection experience required
  • Experience developing manufacturing processes and technologies and designing for manufacturability required
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.


Posted: February 26, 2020, 1:51 pm
Category : Firmware Engineer
Job Type : Permanent
Id : 7848
Region : Twin Cities

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

Core Responsibilities:

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

Experience, Education and Competencies Required:

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

Preferred Experience:

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


Posted: February 21, 2020, 2:13 pm
Category : Project Manager
Job Type : Contract
Id : 7847
Region : Twin Cities

Looking for an Engineering Project Manager to lead remediation of medical device products for EU MDR compliance for a leading medical device manufacturer. You would be part of a core team responsible for the post-market compliance program and accountable to senior staff.

 

POSITION RESPONSIBILITIES:

  • Lead cross functional teams to remediate product technical files for compliance with the new EU MDR.
  • Assess project issues and develop solutions to meet quality, timing, and budget goals and objectives.
  • Oversee and manage the operational aspects of ongoing projects and serve as liaison between project management and planning, project team, and line management.
  • Manage the development and implementation process of products involving departmental or cross-functional teams focused on the delivery existing products under the new EU MDR.
  • Review status of projects and budgets; manage schedules and prepare status reports.
  • Monitor the project from initiation through delivery.
  • Develop mechanisms for monitoring project progress and for intervention and problem solving with other project managers, functional managers, and subject matter experts.
  • Communicate with stakeholders and obtain stakeholder engagement to ensure the required people and other resources are available and committed to meeting project needs.
  • Autonomy: Manages one or more small-scale, developed or mature programs with well-defined program plans and delivery methodologies.  Is accountable for overall program process, performance, and customer satisfaction.
  • Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets .  Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management.
  • Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties .  Modifies programs management processes to improve program.
  • Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team.  Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
  • Leadership and Talent Management: Leads, directs and reviews the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments.  Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management.

 

POSITION REQUIREMENTS:

  • Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. • 214.2(h)( 4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
  • Engineering project management experience in the medical device field preferred.


Posted: February 19, 2020, 9:16 am
Category : Quality Engineering
Job Type : Contract
Id : 7845
Region : Twin Cities

We are seeking an experienced, high caliber Sr. Design Assurance Quality Engineer. The Development Quality team is involved in product development, test method validation, design verification and validation (including hands-on test execution), and sustaining design support.

Position Responsibilities:

  • Lead on-time completion of Design Control Deliverables
  • Drives design quality, reliability, and compliance to standards and regulations
  • Brings electrical and hardware expertise to the product development process
  • Works closely with program teams to ensure timely and accurate completion of Quality deliverables
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Work closely with design test and inspection method development, and lead test method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Builds a strong collaborative partnership with Research & Development to ensure cross-functional customer needs are met without creating barriers to development cost, time and scope
  • 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.

Position Requirements:

  • Bachelor level degree in Electrical or Electronics Engineering, System Engineering or equivalent; advanced degree preferred.
  • Minimum 5 years of experience in a degree-related field
  • Experience with analog/digital circuit design and analysis, plus knowledge of electronic instruments
  • Experience with product development (in a Development or Quality role), test method development and validation, test execution, failure analysis and risk management
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Ability to work in a highly matrixed and geographically diverse business environment and able to follow direction

Preferred qualifications and education:

  • Advanced degree in Electrical, Electronics or Systems Engineering
  • Experience in the implantable medical device field
  • Experience with EMI/EMC, Coexistence, and/or MR environment exposure on active implantable medical devices (simulation and testing)
  • Familiarity with FDA/ ISO and IEC standards and regulations
  • Prior design and development experience in the related field
  • Statistical method and Critical to Quality training and experience
  • Root cause analysis and Finite Element Analysis experience
  • ASQ CQE or other professional certifications
  • Experience working in a broader enterprise/cross-division business unit model


Posted: February 12, 2020, 8:18 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7826
Region : Twin Cities

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

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: January 13, 2020, 8:45 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7817
Region : Twin Cities

The Human Factors Design Engineer applies human performance principles, methodologies, and technologies to the design of humanmachine systems and products. Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes. Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use related risk identification and formal usability validation with intended users. Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized humanmachine interfaces. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: December 18, 2019, 1:03 pm
Category : Software Engineer
Job Type : Contract-to-Hire
Id : 7788
Region : Twin Cities

The Principal Software Architect works with the Software Engineering team and has the prime responsibility of leading the company’s team of Software Engineers, including the formation of software architecture and development plans on projects requiring software/firmware.

Requirements:

  • A Bachelor’s degree in Computer Science/Engineering, coupled with 10+ years of experience in systems software development within the medical device arena is required along with the following key attributes:
  • Skilled in the art of software systems architecture for both embedded software and larger interconnected software systems
  • Experience leading software teams in a multi-disciplined environment
  • Ability to translate user needs and system design specifications and into software requirements
  • Experience designing and developing software and firmware applications in response to functional specifications
  • Experience using industry standard tools and practices to document and visualize software system architecture
  • Experience designing and developing embedded applications with intensive, interrupt driven communications for real-time process control applications using multiple serial channels and communications protocols (proprietary and standard based)
  • Experience in developing cloud software systems and mobile application software
  • Experience in developing wireless applications and devices
  • Experience in sensor and instrumentation integration
  • Experience creating software development plans and schedules
  • Extensive use of debugging tools, including software debuggers and basic use of electronic diagnostic devices for software development, integration, debugging, and troubleshooting
  • Integrate firmware with a variety of hardware platforms and to analyze and troubleshoot the hardware/firmware interface
  • Prefer Certified Cloud Solutions Architect (AWS or Azure)
  • Experience with ISO 13485, IEC 62304, FDA design controls or similar regulatory environment

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

  • Successful communication skills, business acumen and assertive decision-making ability
  • Flexibility to multi-task and perform a wide range of activities
  • Excellent computer skills, including MS Office proficiency

Responsibilities:

  • Work with the greater development team, including Systems Engineering, to develop high level software requirements
  • Design, develop and document software systems architecture for projects ranging from small embedded systems to larger interconnected systems.
  • Support the software development team with translating high level software requirements into detailed software requirements, supporting the documented software architecture
  • Verify that the documented architecture is implemented according to plan through participation in code reviews and design reviews throughout the process
  • Dictate design choices to software developers, including, but not limited to: platforms, coding, and technical levels
  • Create project software development plans, which may favor either a waterfall or agile development process.
  • Work with the program management team on creating accurate software project schedules
  • Maintain and continually improve the software architecture and development process, as technologies and teams evolve
  • Design and develop firmware for embedded systems. Integrate developed applications with other components
  • Mentor junior staff and serve as software onboarding liaison for new employees
  • Assist hardware engineers in development of new platforms and in troubleshooting hardware/software interfaces
  • Document and perform integration, testing, debugging and installation support and activities
  • Participate with project team in the design and implementation of new and enhanced products
  • Develop control algorithms to optimize module and display system performance
  • Interface with design team to support functional test and measurement requirements
  • Initiate and maintain FDA software design control documents
  • Support the manufacturing process by designing and developing production automation software


Posted: November 11, 2019, 8:51 am
Category : Product Manager
Job Type : Permanent
Id : 7785
Region : Twin Cities

Seeking a high caliber Engineering Project Manager who will be responsible for achieving successful execution of various product development initiatives in support of the company's strategy.  The Project Manager serves as a cross-functional team lead with responsibility for defining, developing and delivering new products for our customers while ensuring team commitments are met and communicated in a timely fashion.  This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies. 

 

Responsibilities:

  • Create and maintain multiple project development schedules
  • Monitor and track progress toward project objectives, manage project schedules and budgets, and implement strategies to ensure successful delivery of the project on time and on budget
  • Use broad cross-functional knowledge to provide direction to a cross-functional product development team
  • Provide leadership to ensure overall quality of multiple projects, while minimizing project risks
  • Ensure alignment and communication between groups including Engineering, Operations, Marketing, Clinical, and Quality
  • Perform other related duties and responsibilities, on occasion, as assigned.

 

Qualifications:

  • Exceptional project management skill; knowledge of process and project planning best practices
  • Demonstrated capacity for strategic thinking, project planning and management
  • Excellent communication skills and interpersonal/team effectiveness with an ability to accurately communicate to engineering team and management
  • Clear understanding of the roles and responsibilities of cross-functional project teams
  • Ability to negotiate and manage competing priorities across multiple functional areas
  • Knowledge of FDA, GMP, and ISO 13485; any experience with QSR implementation is desired, but not required.
  • Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
  • Advanced computer skills and working knowledge of Microsoft Office applications.

 



Posted: November 11, 2019, 7:59 am
Category : Mechanical Designer
Job Type : Contract
Id : 7778
Region : Twin Cities

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

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

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



Posted: November 5, 2019, 12:50 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7776
Region : Twin Cities

Seeking a Production Technician to support 3D or Semiconductor sensor products. The Production Technician will support engineering with moderately complex engineering duties and/or hands-on tasks. Involved with the overall production and manufacturing of optical sensors or Semiconductor. Coordinate with hardware and software manufacturing engineering teams. Assist in the develop performance models and test procedures.

Key Responsibilities and Essential Functions:

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

Experience, Education, and Competencies Required:

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


Posted: November 4, 2019, 11:51 am
Category : Firmware Engineer
Job Type : Permanent
Id : 7766
Region : Twin Cities

We are currently hiring an Embedded Linux Software Engineer to develop embedded software for new products and maintain existing product lines through improvement updates. Preference is someone experienced working with open source tools as well as traditional embedded software technologies used in a regulated environment for medical devices.

Responsibilities:

  • Development of C/C++/C++ v11 embedded software applications for both new and existing medical devices
  • Adapt and extend existing embedded Linux applications to add new features to current products, analyze the existing architecture and if applicable, adjust and extend it to allow reuse across additional future products.
  • May coach and develop entry level engineers by sharing knowledge and best practices
  • Assist in planning, estimating, and scheduling software development efforts
  • Review, and guide technical work and issue resolution providing multiple options and ensuring that all work meets requirements and specifications in compliance with the quality system and best practices
  • Maintain frequent communication within and outside of the department in support of engineering activities and project plans
  • Assure appropriate documentation for assigned project
  • Understands and follows requirements of SOPs.
  • Contribute to corrective action development and alternatives.
  • Determine resolution of intermediate technical issues as needed and assures that technical work meets specified requirements.
  • Conducts testing for assigned projects.
  • Prepare documentation associated with engineering activities.
  • Conduct design testing.
  • Operate with a significant amount of latitude and freedom. Within these minimal constraints, may lead medium to large projects; plans and authorizes tests and approves test evaluations; directs and approves documentation and related drawings; designs components, parts or systems of significant difficulty; oversees/approves troubleshooting resolutions.
  • Perform engineering work requiring full competency in all conventional aspect of engineering
  • Plans and conducts work requiring judgment in the independent evaluation, selection and the substantial adaption of standard engineering techniques, procedures and requirements. Plans and coordinates detailed phases of engineering actions for part of a project
  • Performs assignments independently troubleshooting tasks as related to product problems.
  • Performs assignments independently with limited supervision as to expected results.
  • Independently plans, schedules, conducts or coordinates detailed phases of the assigned project.
  • Continuously reviews project team progress and evaluates results accordingly.
  • Works under only general supervision, with direction given only in terms of broadly stated objectives and desired outcomes.

Requirements:

  • Minimum Bachelor's degree in engineering or similar. Software or Electrical Engineering preferred
  • 3-5 years of experience or 2-5 years with an advanced degree.
  • 3+ years of Embedded Linux experience (Buildroot or similar)
  • Experience writing C and C++ applications running on Linux, RTOS, bare metal, uCOS, or similar
  • Experience working with UI frameworks such as Qt, Altia or similar
  • Able to write clean, safe, readable code
  • Applies extensive technical expertise in the engineering field and has knowledge of other related disciplines (Global Product Management, Quality, Regulatory, Sales and Operations)
  • Work under only general supervision from the Engineering Manager, with direction given only in terms of broadly stated objectives and desired outcomes
  • Ability to clearly convey ideas and concepts verbally and in writing

Preferred Requirements:

  • Experience in regulated product development environments preferred
  • Experience in multiple areas of an embedded device (UI, communications, databases, drivers, OS) through all stages of the development process, including for example, requirements, architecture design, coding, test, documentation, and safety analysis highly preferred
  • Experience developing and debugging complex software systems highly preferred
  • Experience planning, scheduling, and conducting multiple phases of a software project highly preferred
  • Experience working in an Agile development environment using tools such as Git, Jira, TFS, etc.
  • Experience in python and bash scripting and creating automated test frameworks preferred
  • Experience coaching and mentoring others in technical matters and related project initiatives preferred
  • Strong influencing skills and ability to convey clear supporting evidence for proposals
  • Ability and willingness to lead and create changes in policy, procedure, technology, and culture


Posted: October 16, 2019, 7:24 am
Category : Project Manager
Job Type : Permanent
Id : 7765
Region : Twin Cities

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

Responsibilities:

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

Requirements:

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



Posted: October 11, 2019, 11:09 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7756
Region : Twin Cities

Seeking a detail-oriented, proactive Certification Project Manager to run numerous certification projects.  Project coordination entails being main point of contact for customer, arranging certifications with test labs,

 

Position Description:

  • Work with test labs and other certification experts to determine what is needed to be able to certify current Company products for sale in counties outside of North America and Europe
  • Gather certification quotes from test labs and estimate support labor for potential certification projects.
  • Writing statement-of-work documents, which function as project proposals
  • Consult with internal Company employees to find test reports, product information, and any other information or help needed to complete new country certifications for existing Company products
  • 30+ hours per week
  • Certification/regulatory experience required

 

Posted: September 26, 2019, 1:24 pm
Category : Controls Engineer
Job Type : Contract
Id : 7725
Region : Twin Cities

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

Position Requirements:

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


Posted: August 28, 2019, 12:46 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7724
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer for the following duties:

  • Develop mechanical automation designs from customer specifications
  • Provide technical direction in a team-oriented work environment
  • Lead all design aspects for assigned projects in a team-oriented work environment
  • Develop and implement design standards
  • Perform or participate in internal project design reviews
  • Interface with customers on technical projects
  • Use analytical tools to assist in the design process
  • Interface with suppliers

 

Skills/Qualifications:

  • Experience with 3D CAD modeling packages - Solidworks and Unigraphics a plus
  • Ability to manage an automation design from the concept phase through modeling and detailing
  • Experience in a "systems" approach to automation design
  • Demonstrated ability to own and drive projects to completion
  • The drive to consistently deliver on commitments

 

Position Requirements:

  • BS or MS in Mechanical Engineering
  • 4 – 6 years of experience in automated design
  • Only those persons authorized to work permanently for any employer in the US will be considered


Posted: August 28, 2019, 12:44 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7657
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: May 14, 2019, 11:46 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 7626
Region : Twin Cities

Seeking a Senior Software Test Engineer to provide end to end development of TestStand/LabVIEW solutions for custom functional test systems including, writing requirements; test system development and integration; acceptance testing and technical support.

Major Areas of Accountability:

  • Develop software test system requirements
  • Design software solutions that satisfy test system requirements
  • Lead or participate in design review meetings
  • Collaborate with other engineering disciplines to ensure effective overall system design
  • Provide technical leadership on projects involving multiple engineers, including leading the overall design approach partitioning work among the team and sequencing detailed design activities to support the overall project schedule
  • Support the sales process by providing technical expertise in customer proposals
  • Provides effective communication with project team members, including project status, risks and suggestions to project leadership
  • Collaborate with customers as needed to accomplish customer goals

Education and Experience:

  • Bachelor’s Degree in Electrical Engineering, Computer Science or equivalent experience in a test engineering environment
  • 5 – 10 years of work experience using TestStand and LabVIEW
  • CLD or CLA is preferred
  • Ability to design TestStand or LabVIEW architectures based on system requirements
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading test software
  • Solid analytical skills; able to resolve technical problems with innovative solutions
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Effective verbal and written communication skills
  • Capacity to deal with a high workload and deadline pressure
  • Requires a strong initiative, proactive nature and a sense of urgency
  • Ability to travel 0% - 10% to client locations for meetings and/or system installations
  • Ability to work extended hours as necessary to meet deadlines
  • Must be able to perform in a team environment with good interpersonal skills with commitment to the highest quality achievable
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: April 4, 2019, 12:07 pm
Category : Controls Engineer
Job Type : Permanent
Id : 7556
Region : Twin Cities

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

Requirements

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


Posted: December 6, 2018, 9:22 am
Category : Software Engineer
Job Type : Contract
Id : 7548
Region : Twin Cities

 

Essential Job Functions & Responsibilities:

  • Embedded firmware design and implementation
  • Support projects for new and existing customers. This will require theoretical analysis, simulation analysis, software/firmware implementation, code review, documentation, and hardware/software integration testing.
  • Support communication protocol development efforts: network security protocols, wireless mesh networking and network security
  • Support development in multiple operating systems:  Linux, FreeRTOS, bare metal, Windows, etc.
  • Coordinate and work collaboratively cross functionally as well as with other software development teams in the organization
  • Lead software efforts being self-directed as well as leading small software teams
  • Mentor junior engineers in current trends and best practices
  • Provide outstanding documentation of software designs
  • Assist with certification testing
  • Coordinate software releases with internal and external stakeholders
  • Participate in appropriate training and development programs to maintain and enhance job-related skills

 

Required Qualifications:

  • Minimum: BS or MS in Computer Engineering, Electrical Engineering or Computer Science
  • 10+ years of related experience
  • Direct experience in programming in C for real-time embedded systems
  • Significant experience working with 32-bit microcontrollers in a flash and RAM constrained system
  • Significant experience with microcontroller peripherals and interfaces: UART, SPI, ADC, PWM, Timers, etc.
  • Development experience with embedded Linux (layers below application) and RTOS/bare metal
  • Skilled in the use of test and debug equipment: oscilloscopes, logic analyzers, multi-meters, spectrum analyzers, etc.
  • Demonstrated ability to function self-directed in leading software engineering efforts
  • Demonstrated ability to lead a small team of software engineers, i.e. task planning/managing, mentoring, defining core architecture, etc.
  • Good communication and team skills, both externally and internally
  • Solid debugging, troubleshooting, and problem solving ability
  • Eagerness to collaborate with team members and coworkers within the organization
  • Solid experience in delivering quality documentation (Requirements, Design Doc's, test plans)
  • Experience working through all phases of software development (Concept, architecture, development, test, release to manufacturing)

 

Preferred Qualifications:

  • Experience in developing Linux Kernel drivers, and low level Linux protocols
  • Experience in developing in real-time operating systems
  • Experience with RF communication
  • Experience with RF protocols at the PHY/MAC/NWK layers such as 802.15.4, zigbee, BLE, or Wi-Fi
  • Experience with networking protocols
  • Experience with a revision control system, GIT is preferred
  • Python experience
  • Experience with unit testing


Posted: November 20, 2018, 11:57 am
Category : Sales
Job Type : Permanent
Id : 7488
Region : Twin Cities

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

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

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

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

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

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

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


 

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

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

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

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



Posted: September 6, 2018, 8:20 am
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 : 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