Search Jobs

Find all kinds of technical jobs in Minneapolis / St. Paul





Development Resource Group

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

Category : Electrical Engineer
Job Type : Contract
Id : 7998
Region : Twin Cities

The Electrical Engineer researches, develops, designs, and tests electrical components, equipment, systems, and networks. Designs electrical equipment, facilities, components, products, and systems for commercial, industrial, and domestic purposes for a major medical device company.

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

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


Posted: September 23, 2020, 7:16 am
Category : Electrical Engineer
Job Type : Contract
Id : 7996
Region : Twin Cities

Seeking Principal Electrical Engineers for Design Characterization (DCT) and Verification (DVT) of a new medical device product. DCT and DVT tasks may include developing test methods, writing protocols, performing bench testing, and writing reports. Must be skilled with electronic lab testing and troubleshooting, and proficient at authoring documentation.

 

Responsibilities may include the following and other duties may be assigned. Researches, develops, designs, and tests electrical components, equipment, systems, and networks. Designs electrical equipment, facilities, components, products, and systems for commercial, industrial, and domestic purposes. Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

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


Posted: September 23, 2020, 7:16 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7995
Region : Twin Cities

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

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

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


Posted: September 23, 2020, 7:15 am
Category : Manager
Job Type : Contract
Id : 7994
Region : Twin Cities

Seeking a Program Manager to oversee and manage the operational aspects of ongoing projects and serve as liaison between project management and planning, project team, and line management for a major medical device company. This position manages the development and implementation process of company's products and services involving departmental or cross functional teams focused on the delivery of new or existing products. Reviews status of projects and budgets; manages schedules and prepares status reports. Monitors the project from initiation through delivery. Assesses project issues and develops resolutions to meet productivity, quality, and client satisfaction goals and objectives. Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients.

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

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


Posted: September 22, 2020, 9:56 am
Category : Quality Manager
Job Type : Contract-to-Hire
Id : 7993
Region : Twin Cities

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

Responsibilities:

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

Qualifications:

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


Posted: September 21, 2020, 1:41 pm
Category : Material Manager
Job Type : Contract-to-Hire
Id : 7992
Region : Twin Cities

As a Manufacturing Engineer, you will be responsible for daily manufacturing from production documentation, programming, through production improvements. Activities will include new product introduction, SMT, AOI, Robots, XY Gantry, Vision, AI, programming. Along with 3D CAD design, method improvements, paperless manufacturing software, and Customer communication.

The ideal candidate will need to be a self-starter and enjoy working in a team environment. Our day starts with a team meeting and project updates. We're looking for a precision-oriented professional with highly developed leadership qualities and the ability to work efficiently within manufacturing. The successful candidate's primary function and the role will deal with the conception, CAD design, and development of new flexible circuit assemblies and equipment. We're looking for someone who enjoys contributing to an innovative, forward-thinking team and who can always keep the end-user in mind.

Tasks:

  • Implement Aegis paperless manufacturing software platform.
  • Implement traceability to the board level.
  • New product documentation for production.
  • New product 2D and 3D CAD and tooling.
  • New product programming including Printer, Pick & Place, Oven, AOI, ET, Robots, Etc.
  • Customer assistance in 2D & 3D CAD design & BOM structures.
  • Evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements
  • Apply working knowledge of product design and assembly to the manufacturing process
  • Create processes and procedures to help the company meet budgetary goals as well as performance quotas
  • Design and develop new products and product mock-ups alongside the creative team
  • Participate in brainstorming sessions and cross-departmental meetings to ensure collaborating and cohesion
  • Establish an effective and efficient work sequence
  • Devise new solutions to existing manufacturing problems
  • Develop standardized design criteria across all product lines

Skills and Requirements:

  • Bachelor's Degree - Manufacturing Engineer
  • 2+ years' Manufacturing Engineering Experience. SMT Experience a plus.
  • Strong organizational, analytical, and communication skills
  • Proficient with Windows operating systems and Microsoft Office programs
  • Experience with 2D & 3D CAD required.
  • Experience with Programming required.


Posted: September 21, 2020, 1:38 pm
Category : Mechanical Engineer
Job Type : Contract-to-Hire
Id : 7991
Region : Twin Cities

Seeking a Mechanical Engineer responsible for designing new equipment and develop improvements for current equipment.

POSITION RESPONSIBILITIES:

  • Create and maintain BOMs and drawings for new and existing machinery
  • Create manufacturing drawings
  • Keeping engineering documentation up to date and organized
  • Repairing equipment
  • Investigating production problems
  • Making improvements to current operations to enhance efficiency
  • Follow Quality Management System policies and procedures.

POSITION QUALIFICATIONS:

  • B.S. Mechanical or equivalent
  • A minimum of 5 years related experience required.
  • AutoCad/Inventor expertise
  • Be able to perform hand calculations, including but not limited to, heat transfer, fluid dynamics and statics, mechanical stress and balance of masses and energies
  • Machining knowledge
  • Production environment knowledge


Posted: September 21, 2020, 11:02 am
Category : Software Engineer
Job Type : Contract-to-Hire
Id : 7990
Region : Twin Cities

Seeking a talented Software Programming Engineer to be responsible for developing and improving new processes on our robotic lines using the following languages; VB.Net, PacScript (Denso Robots), ACSPL+(ACS Motion Control), Mint(ABB Motion Control), Orion2, Microsoft Access)

POSITION RESPONSIBILITIES:

  • Process Control/ Implementation/Improvement.
  • Designing/managing/querying Microsoft Access Database.
  • Keeping programming documentation up to date.
  • Creating work instructions for manufacturing employees.
  • Investigating production problems.
  • Making improvements to current operations to enhance efficiency.
  • Maintaining statistical records and process control databases.
  • Follow Quality Management System policies and procedures.

POSITION QUALIFICATIONS:

  • B.S. Electrical Engineering /Data Science or equivalent.
  • A minimum of 5 years related experience required.
  • C, C#,Visual Basic Programming expertise.
  • Microsoft Access expertise, SQL knowledge.
  • Motion Control and Machine vision (Cognex) experience.
  • Familiarity with contract manufacturing environment.
  • CAD / Autodesk Inventor knowledge.


Posted: September 21, 2020, 10:59 am
Category : Packaging Engineer
Job Type : Contract
Id : 7989
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.

POSITION REQUIREMENTS:

  • Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. 4
  • Advanced degree preferred.


Posted: September 21, 2020, 9:32 am
Category : R&D Engineer
Job Type : Contract
Id : 7988
Region : Twin Cities

Seeking a Senior R&D Engineer to serve as a leader to design, develop and provide technical expertise in post-market released medical devices. Lead or support released product engineering teams through planning, developing, and performing testing and analysis during product change implementation to drive improved product performance and manufacturability, reduce cost, and / or ensure supply continuity. Partner with Quality, internal Manufacturing, Suppliers including CM/OEM, Marketing, Regulatory Affairs and other key functions to achieve business goals.

As a Senior R-D Engineer you will focus on maintaining design integrity through the post-market lifecycle of products. This role supports and sometimes leads projects which are in alignment with manufacturing operations or R-D sponsored initiatives. The role requires independent work, effective management and prioritization of multiple concurrent projects and tasks in an ambiguous environment.

POSITION RESPONSIBILITIES:

  • Represents the R&D organization for a specific product platform. Provides design technical guidance and consultation throughout cross-functional team projects to ensure effective planning, execution, and completion;
  • Reviews, assesses impact to assure design requirements are continuously met, and approves design and manufacturing process changes;
  • Defines, plans, and executes on owned design control evidence deliverables and across led projects (including CAPA projects);
  • Maintains mechanical designs by updating drawings and design documentation to the latest national and international standards;
  • Performs or guides lower level personnel in design testing, including design sample and equipment preparation.
  • Develops, troubleshoots, configures, and implements electrical / mechanical tests;
  • Uses statistical and structured problem-solving techniques, experimental design methodologies and analytical modeling, facts, and data to promote and facilitate problem definition, investigation for root cause, the design of medical devices, and/or the basis for change implementation;
  • Creates and ensures detailed, accurate, and compliant engineering documentation in support of changes. Examples are: measurable and verifiable product specifications and mechanical drawings, change orders, and Equipment Qualification, Test Method Validation, and Design Characterization / Verification / Validation Testing protocols and reports.
  • Supports analysis and evaluation of returned products;
  • Provides input to regulatory submissions;
  • Communicate status frequently;
  • Performs job functions in accordance with applicable standards, such as GMP, IEC and ISO standards. Ensures understanding of all quality policy/system items that are personally applicable. Trains to and follows all quality policy / system work-related procedures to ensure quality system compliance and high-quality work.

Must Have – Minimum Qualifications:

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 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have:

  • Degree related to mechanical engineering or a related field.
  • Experience in a Class II medical device industry;
  • Experience with design or manufacturing process development and validation;
  • Experience using statistical techniques (e.g. use of statistical software like Minitab, DOE, Monte Carlo, ANOVA, GR&R, or Six Sigma tools and principles);
  • Experience using structured problem-solving techniques (e.g. CAPA, DMAIC processes, FMEA, FEA, FTA, or Lean tools and principles);
  • Experience in Design for Lean Sigma or Design for Six Sigma (or equivalent);
  • Experience working with Design for Manufacturing and Assembly or Design for Reliability and Manufacturability (or equivalent);
  • Project or Program Management experience or PMI PMP certification.


Posted: September 18, 2020, 6:26 am
Category : R&D Engineer
Job Type : Contract
Id : 7987
Region : Twin Cities

Seeking an R&D Engineer with work on cardiac occluders and associated delivery system - remediation and continuous improvement activities for a major medical device company.

  • Perform, summarize and present research to assist the team in meeting project requirements
  • Participate in or lead problem-solving investigations
  • Develop or improve test methods utilizing skill sets including mechanical design, prototyping, problem solving and measurement systems analysis
  • Work with cross-functional teams to establish the device lifetime for each product
  • Support materials compliance teams with BOM, identification and verification of patient contacting and invasive component list
  • Updates to DHF, design inputs/outputs and product specification as applicable (from detailed gap assessment)
  • Update CAD files, design prints as necessary (materials compliance)
  • Support design quality engineers with risk management updates (frequency of occurrence and assessment of risks)
  • Ensure biocompatibility documentation is complete, update as necessary with shared biocompatibility services
  • Execute V&V work (to current standards as applicable)
  • Support inputs for General Safety and Performance Requirements (GSPR)

Requirements:

  • 3-7 years’ experience
  • Familiar with design controls and implantable devices
  • Continuous improvement / sustaining engineering experience
  • Previous work on U.S. class II or class III devices, class III preferred
  • Design assurance / development quality experience a plus
  • Experience working with nitinol a plus
  • Experience working with mechanical devices a plus
  • Working knowledge of the E.U. medical device regulation a plus


Posted: September 11, 2020, 11:06 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7986
Region : Twin Cities

Looking for 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: September 10, 2020, 8:47 am
Category : Reliability Engineer
Job Type : Contract
Id : 7985
Region : Twin Cities

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

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

 

Posted: September 8, 2020, 9:01 am
Category : Reliability Engineer
Job Type : Contract
Id : 7983
Region : Twin Cities

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


Posted: September 3, 2020, 2:08 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7982
Region : Twin Cities

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

Primary Responsibilities:

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

Education/Experience:

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


Posted: September 3, 2020, 7:40 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7981
Region : Twin Cities

Seeking a Senior Quality Engineer / Trending Engineer to conduct monitoring and trending of field performance for market released medical device products through the entire product life cycle. Trend and analyze complaint, service and returned product analysis data using established procedures and analysis tools. Compare observed rates to established expectations. Consult with other groups to determine when observed trends should be escalated for additional investigation. Provide support to these investigations through the retrieval and analysis of relevant data. Generate regular reports documenting the results. This position will work with the Complaint Handling and Returned Product Analysis teams to ensure that complaint codes are properly assigned in the complaint handling system. Where appropriate, provide recommendations to improve the coding process. This engineer will also provide the data necessary to support the corrective action (CAPA) and other internal processes (regulatory, clinical, R&D, etc.). Respond to requests for information related to product performance from competent authorities, company geographies, customers and management. Support Reliability Engineering with data collection and analysis. Regularly communicate product performance data to the organization (via email, product performance meetings and management reviews).

Position Requirements:

  • Bachelor’s degree in Engineering, Statistics, Mathematics, or other science field
  • Proficiency with Excel and other Microsoft office tools
  • Demonstrated time management, continuous improvement, problem solving & critical thinking skills
  • Well-developed written and oral communication skills

Nice to Have

  • 3-5 years of experience in relevant area
  • Experience in the implantable medical device industry.
  • Working knowledge of medical device regulations (21 CFR 820, ISO 13485 & 14971)
  • Experience with trending and analysis of complex data from multiple sources
  • Experience with statistical tools for hypothesis tests, confidence intervals, and reliability analysis
  • Strong proficiency with analytics software such as Spotfire, Tableau, JMP, Minitab, etc.
  • Working knowledge of tools such as FMEAs and Reliability Predictions
  • Experience with query/report validation


Posted: September 1, 2020, 12:09 pm
Category : Project Manager
Job Type : Contract
Id : 7980
Region : Twin Cities

The Principal Project Engineer will provide project management support on new product development teams to the Core Team Operations Representative (CTOR) role as part of a cross-functional operations team. This role will assume responsibility for planning and execution various Operations deliverables, including but not limited to predictive analysis of cost standards, yield expectations and capacity assessments. The candidate will own the planning and execution of program builds in support of development and commercialization of new products, while ensuring adherence to schedule, budget, and compliance to internal quality requirements. The candidate may also be the single point of contact for all operations aspects of a smaller scale new product development / sustaining engineering program and own overall project execution with respect to schedule, budget, and compliance to internal quality requirements for Operations activities.

 

Project Management:

  • Meet following deliverables through cross-functional collaboration
  • Provide CTOR with cost inputs from a engineering build plan perspective as input to program budget planning and reporting
  • Drive build readiness to align process and component readiness to agreed levels and timelines. Drive follow-up on logistical issues and action items associated with program builds
  • Provide onsite or remote support to build facilities during program builds
  • Risk Management for program builds to drive predictability and to balance cost and schedule within contract tolerances
  • Coordinate with extended operations team for materials required to support process development, component characterization and qualification, and builds identified by the development team.
  • Facilitate readiness reviews and preparation for key program builds
  • Drive follow-up on observations / issue action items associated with program builds
  • Collaborate on build device disposition during / after build to maximize units for testing
  • Quality System Compliance, Design History File, and Regulatory Submissions documentation
  • Author and maintain Design Transfer Plan, including identification of Operations objectives and ensure implementation schedules and execution plans based on Design Transfer Plan
  • Resolve schedule issues and identify recovery plans as applicable
  • Communicate and escalate key issues and concerns for budget/cost and schedule completion to CTOR
  • Manage follow-up associated with Post Design Validation Change Tracking and track completion status
  • Coordinate input to Design Validation readiness review and validity report

Communication:

  • Ensure timely and thorough updates at various levels of the organization (Program/ Project Team, Operations Functional / Management)
  • Polished communication skills including effective public speaking and presentation
  • Additional support to the CTOR:
  • Support CTOR with completing other special assignment activities per guidance from CTOR

Required Qualifications:

  • Experience in Operations extended function (supplier management, component engineering, manufacturing, global supply chain, packaging, pharmaceutical operations, or process development)
  • Bachelor of Science Degree in scientific discipline (e.g. Electrical, Mechanical, Chemical, BioMedical, etc) with a minimum of 9 years of relevant operational experience or 7 years of experience with MS degree
  • Minimum of 5 years experience in successful operations project / program management


Posted: September 1, 2020, 6:18 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7978
Region : Twin Cities

Seeking a Human Factors Design Engineer to apply knowledge of human performance (perceptual, cognitive and motor skills) and human factors techniques to identify user needs, develop requirements, and inform/contribute to design across the product development cycle. Activities will include: field research to identify user needs and work flows; task analysis; software and hardware user interface design; conducting usability tests; data analysis; communicate research outcomes to key stakeholders; and risk assessment.

Position responsibilities under the guidance of HFE Lead:

  • Conduct field studies/literature reviews/research and apply the outcomes to requirements definition, concept development, and detailed design
  • Work closely with marketing, product planning, engineering, manufacturing, quality assurance, technical communications, and regulatory to produce design solutions that meet user needs and consider business needs and manufacturing constraints.
  • Contribute to the development of physical mock-ups and interactive prototypes of design concepts
  • Plan and conduct usability tests of product concepts; analyze data; document evaluation methods and results; and present design recommendations to the product development team.
  • Full-time (40-hour/week) time availability.
  • Able to travel globally to support project needs as required.

Position Requirements:

  • Bachelor’s Degree in human factors-related discipline with 3+ years of experience with Bachelors Degree; or 1+ years of experience with Masters Degree
  • Advanced knowledge in human physical and psychological capabilities and limitations, and methods used to study them.
  • Experience planning and conducting human subjects research studies, analyzing data, and reporting results verbally and in writing

Desired/Preferred Qualifications:

  • Graduate degree in human factors-related discipline: Kinesiology, Psychology, Industrial Design, or a related field.
  • Be familiar with regulatory and industry requirements for Human Factors in medical device development.
  • Experience designing in a regulated technical (preferably medical device) environment.
  • Expert with Microsoft Office Suite
  • Experience designing with Adobe Design Suite
  • 3D CAD concepting and printing
  • Data visualization
  • Video production
  • Systems Engineering


Posted: August 28, 2020, 8:20 am
Category : Reliability Engineer
Job Type : Contract
Id : 7977
Region : Twin Cities

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

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


Posted: August 27, 2020, 8:28 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7976
Region : Twin Cities

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

  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Entry level individual contributor on a project or work team. Works with close supervision.
  • Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
  • Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
  • Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
  • Leadership and Talent Management: N / A job at this level is focused on self-development.R
  • equired Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree, 0 years of experience required.


Posted: August 26, 2020, 6:30 am
Category : Electrical Engineer
Job Type : Contract
Id : 7975
Region : Twin Cities

The Principal R&D Engineer serves as a leader to design, develop and launch medical devices as well as support existing products. Responsibilities may include providing engineering and project management leadership to new product development and sustaining engineering teams, as well as performing testing and analysis on medical devices for improvement and cost reduction.

This position requires collaborative interaction with Manufacturing, Quality, Marketing, Regulatory Affairs and other key functions to achieve business deliverables.

POSITION RESPONSIBILITIES:

  • Serve as a project leader / manager for cross-functional projects
  • Conduct product testing and analysis on existing products for improvement, cost reduction and to support CAPAs
  • Establish product requirements, prototype concepts, and verify and validate designs and processes
  • Define and develop tests and test methods to meet product requirements
  • Perform risk / failure mode assessment and conduct performance and safety testing
  • Institute design changes based on internal and external customer feedback
  • Write protocols, reports and presentation of analytical and interpretative nature to communicate results
  • Provide technical mentoring to less experienced engineers
  • Interact and build relationships with physicians as well as sales and marketing partners
  • Develop strong partnerships and work effectively with cross-functional team members
  • Perform job functions in accordance with applicable GMP and ISO standards, especially IEC 60601 Product Safety Standards for Medical Devices for the latest editions
  • Comply with applicable FDA and international regulatory laws and standards, especially ISO 13485 and ISO 14971

BASIC QUALIFICATIONS:

  • Bachelor’s degree in electrical or biomedical engineering or related technical field.
  • 10+ years of applicable work experience in an engineering role
  • Medical device industry experience including design controls, quality system regulations and product development processes
  • Excellent oral and written communication skills
  • Ability to effectively manage and prioritize multiple tasks and projects in an ambiguous environment

DESIRED/PREFERRED QUALIFICATIONS:

  • Experience with radiofrequency ablation products, endovascular catheter products, processing and technologies
  • Experience with capital equipment design
  • Experience with software development and software validation testing for medical device products
  • Experience with failure analysis, process improvements and change management
  • Experience with manufacturing processes and Contract Manufacturers
  • Strong problem solving capabilities



Posted: August 24, 2020, 6:31 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7974
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer to develop engineering solutions for new and existing products through frequent interaction with Process, Manufacturing, and Quality Engineering. Provide recommendations based on in-depth analysis. May lead projects within job area and may provide work direction to other employees within job area.

POSITION RESPONSIBILITIES:

  • Proven experience executing product changes regulated by design control.
  • Proven experience applying product development process to a derivative product line.
  • Understands the requirements of cross-functional internal customers.
  • Understanding and wide application of technical principles, theories and concepts in the field.
  • Participates in preclinical evaluations.
  • Good clinical indications experience.
  • Observation and good understanding of human clinical procedures.
  • Responsible for subset of product design.
  • Develops product specs, test methods, equipment.
  • Creates, reviews and approves protocols/reports.
  • Interprets test results.
  • Working knowledge of DRM and statistics.
  • Responsible for subsystems of designs or smaller designs in their entirety.
  • Completes tasks associated with area of responsibility within assigned schedule.
  • Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA’s, contributes to assigned sections of submission documents.
  • Working knowledge of internal quality system (e.g. SOPs, DOPs), external quality standards, and statistical methods.

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Mechanical Engineering/ Materials Science / Chemical Engineering, or related technical field
  • 4+ years of relevant experience with BS, 2+ years with MS, 0+ years with PhD
  • Experience developing products and/or processes
  • Demonstrated problem solving skills
  • Demonstrated verbal and written communication skills
  • Demonstrated leadership and initiative

DESIRED/PREFERRED QUALIFICATIONS:

  • Experience with medical device-based products, processes and technologies
  • Medical Device / Pharmaceutical or other regulated Industry experience


Posted: August 24, 2020, 6:20 am
Category : R&D Engineer
Job Type : Contract
Id : 7970
Region : Twin Cities

The Senior Human Factors Design Engineer applies human performance principles, methodologies, and technologies to the design of human-machine systems and products for a major medical device company. This position 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. This engineer Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area.
  • Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: August 11, 2020, 12:44 pm
Category : Project Manager
Job Type : Contract
Id : 7715
Region : Twin Cities

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

Key Responsibilities:

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

Additional Responsibilities:

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

MINIMUM JOB REQUIREMENTS:

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


Posted: August 7, 2020, 11:25 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7967
Region : Twin Cities

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

  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: August 6, 2020, 6:21 am
Category : Software Engineer
Job Type : Contract
Id : 7965
Region : Twin Cities

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

 

Job Responsibilities:

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

 

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

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

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


Posted: July 31, 2020, 1:42 pm
Category : Test Engr - Technical
Job Type : Contract
Id : 7962
Region : Twin Cities

The Test Engineer in the Radio Quality function has primary responsibility for the planning and executing of wireless and telecommunications compliance testing to enable world-wide radio frequency approvals for company products. Under the general direction of the Radio Quality Manager, the Test Engineer in the Radio Quality group is responsible for working cross-functionally to understand device and instrument functionality, configure test samples, understand wireless and telecommunication requirements, and execute compliance testing, as well as planning and coordination of radio and telecommunication activities. In addition, the Test Engineer may review or develop compliance documentation, engineer test set-ups, and create procedures to support internal requirements.

Qualifications:

  • Basic knowledge of RF instrumentation and other electronic lab equipment such as spectrum analyzers, signal and waveform generators, oscilloscopes, power meters and sensors, and RF amplifiers.
  • Understanding of active implantable medical device functions and device programming at a system and firmware level.
  • Skills to interpret and understand regulatory requirements and standards.
  • Experience with test equipment, set-ups and test methods used to assess wireless and telecommunications compliance.
  • Operation of medical device programmers and associated instruments.
  • Knowledge and basic understanding of 50 ohm measurement systems, shielding and filtering.

Preferred Qualifications:

  • Familiar with radio and EMC regulations and standards such as US FCC, Canada ISED, European ETSI and Directives.
  • Experience in evaluating products which contain wireless and telecommunication systems.
  • Knowledge of wireless communication systems used in active implantable medical devices and instruments.
  • Working knowledge of LabVIEW and MATLAB.
  • Knowledge and basic understanding of electromagnetic interference (EMI) and electromagnetic compatibility (EMC).

Education:

  • 4 year degree in an electronics-related field such as Engineering Technology, Electrical Engineering, Systems Engineering, Computer Engineering or similar discipline.

Experience:

  • 3-5 years of experience with a desire to perform hands-on activities and interface with product development teams.


Posted: July 29, 2020, 12:28 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7960
Region : Twin Cities

As a Reliability Engineer, you will have responsibility to ensure consistent, timely, and accurate risk evaluations of Medical Device therapies, diagnostics, devices, and systems throughout the lifecycle of the product. You are also expected to monitor and understand the performance of company products. This position may also include reliability engineering responsibilities such as ensuring products are developed and manufactured with highest product quality and meet all applicable product quality, design and manufacturing process requirements. Also, this role may support CAPA and design/process changes for released product.

Responsibilities may include the following and other duties may be assigned.

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


Posted: July 29, 2020, 10:05 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7959
Region : Twin Cities

The Risk Management Engineer assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Job Duties:

  • Execute and support on-time completion of Risk Management Deliverables
  • Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Support Risk Management / Cybersecurity activities from product Concept through product obsolescence, including post-market activities and support for submissions.
  • Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications:

  • Bachelor level degree in Engineering or Technical Field, advance degree preferred
  • 3 - 6 years' experience
  • Previous engineering experience preferred
  • Solid communication and interpersonal skills
  • 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 maintain regular and predictable attendance.



Posted: July 29, 2020, 9:57 am
Category : Mechanical Designer
Job Type : Contract
Id : 7957
Region : Twin Cities

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

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


Posted: July 27, 2020, 9:20 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7956
Region : Twin Cities

Seeking a New Product Introduction (NPI) 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.

POSITION REQUIREMENTS:

  • Bachelors Degree
  • 2-4 years of experience in Medical Device Company


Posted: July 27, 2020, 8:59 am
Category : Software Test Engineer
Job Type : Contract
Id : 7950
Region : Twin Cities

Seeking a Software Verification Engineer to join our team. This Engineer will bring testing expertise to the innovative and fast-paced verification team. This high caliber, 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 company practices, 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: July 22, 2020, 2:16 pm
Category : Software Engineer
Job Type : Contract
Id : 7949
Region : Twin Cities

We are recruiting for a Software Engineer to join our team. In this technical role, you will be a critical contributor in the development and deployment of software solutions to support our development programs and building compelling products within Electrophysiology Division. Under the guidance and direction of an experienced engineer, you will be responsible for developing use cases, reviewing software design, and decomposing higher level requirements in the development of software applications embedded in diagnostic cardiology devices. Additionally, you will participate in all phases of the software lifecycle, including concept development, requirements, design, implementation, and testing.

Primary Responsibilities:

  • Participate in software feature definition activities
  • Works with Software Development, Systems Engineering, Human Factors, Clinical Engineering, and other stakeholders to develop software use cases.
  • Generates clear and concise software requirements
  • Creates tracing from higher level requirements to software requirements
  • Reviews software designs to ensure they implement the appropriate software requirements
  • Assists in software integration activities to ensure software behaviors are appropriate
  • As a team member, contribute significantly to completion of various project activities, from definition, identifying software functional requirements, implementation, code reviews, and final release according to medical device development processes

Required Qualifications:

  • Bachler’s Degree in Engineering (Computer, Electrical, Computer Systems, Systems, or Software), Computer Science, or related discipline
  • 1-3 years of software engineering design and development or systems engineering experience
  • Knowledge of 62304 and other standards applicable to Class II and Class III medical devices
  • Demonstrated knowledge and experience working with C++
  • Experience with creating and managing requirements and translating them into effective architectures and software design
  • Previous experience working in a regulated industry such as automotive, aerospace, healthcare, or defense
  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

Preferred Qualifications:

  • Master’s Degree in Engineering (Computer, Electrical, Computer Systems, or Software), Computer Science, or related discipline
  • Well versed in draft FDA Cybersecurity Guidance and GDPR
  • Experience with complex electromechanical systems including hardware, embedded firmware, disposables, and software


Posted: July 22, 2020, 1:09 pm
Category : Quality Engineering
Job Type : Contract
Id : 7948
Region : Twin Cities

We are seeking a high caliber Development Quality Engineer I. This engineer assures new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Each employee can make a difference and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Responsibilities:

  • Execute on-time completion of design control deliverables
  • Design verification and validation test planning
  • Design verification and validation test protocols, execution and reports
  • Design input output trace matrix
  • Design History File organization
  • Customer, system, and product requirement review
  • Regulatory responses and submissions
  • Risk/hazard analysis and risk management plan/reports
  • Design specification reviews
  • Quality plans
  • Design change plan/reports
  • Investigate internal and external audit findings and write responses
  • Corrective and preventive action resolution
  • Complete document change requests
  • Ability to work independently with minimal/no supervision
  • Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Support all Divisional initiatives as identified by divisional management and in support of quality management systems (QMS), environmental management systems (EMS), and other regulatory requirements
  • Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including up to 10% travel and regular predictable attendance

Minimum Experience, Education & Knowledge:

  • 0-2 years’ experience in R&D or Quality role
  • Bachelor level degree in an Engineering Discipline or other Technical Field
  • Solid communication and interpersonal skills
  • Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
  • Advanced computer skills, including and report writing skills
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail

Preferred qualifications and education:

  • Degree in Mechanical, or Biomedical Engineering
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, statistical/data analysis
  • Prior medical device experience preferred
  • Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485



Posted: July 22, 2020, 12:54 pm
Category : R&D Engineer
Job Type : Contract
Id : 7944
Region : Twin Cities

Seeking a Senior R&D Engineer – EU MDR to work on cardiac occluders and associated delivery system - remediation and continuous improvement activities for a major medical device company.

POSITION RESPONSIBILITIES:

  • Perform, summarize and present research to assist the team in meeting project requirements
  • Participate in or lead problem-solving investigations
  • Develop or improve test methods utilizing skill sets including mechanical design, prototyping, problem solving and measurement systems analysis
  • Work with cross-functional teams to establish the device lifetime for each product
  • Support materials compliance teams with BOM, identification and verification of patient contacting and invasive component list
  • Updates to DHF, design inputs/outputs and product specification as applicable (from detailed gap assessment)
  • Update CAD files, design prints as necessary (materials compliance)
  • Support design quality engineers with risk management updates (frequency of occurrence and assessment of risks)
  • Ensure biocompatibility documentation is complete, update as necessary with shared biocompatibility services
  • Execute V&V work (to current standards as applicable)
  • Support inputs for General Safety and Performance Requirements (GSPR)

POSITION REQUIREMENTS:

  • 3-7 years’ experience
  • Familiar with design controls and implantable device
  • Continuous improvement / sustaining engineering experience
  • Previous work on U.S. class II or class III devices, class III preferred
  • Design assurance / development quality experience a plus
  • Experience working with nitinol a plus
  • Experience working with mechanical devices a plus
  • Working knowledge of the E.U. medical device regulation a plus


Posted: July 17, 2020, 8:00 am
Category : Systems Engineer
Job Type : Contract
Id : 7943
Region : Twin Cities

The Product Engineer is a specialty under the umbrella of a systems engineering discipline that focuses on the integration of package and labeling requirements within the larger therapy system for a major medical device company. The position will provide technical leadership for the Product Engineering Team, owning the packaging and labeling product architecture, requirement definition, requirements trace, verification/validation support, and manage associated Safety Risk Management interfaces.

Specific responsibilities include:

  • Work with peer systems engineer(s) during development of user needs & intended uses.
  • Ensure seamless and cohesive development and maintenance of product architecture and requirements to support the entire product lifecycle.
  • Develop and maintain the communication channels required to effectively and efficiently manage workflows between package design engineering, systems engineering, human factors engineering, risk management, and regulatory affairs.
  • Provide independent review of packaging and labeling design change control, and verification /validation rationale.
  • Contribute and build domain knowledge around implantable medical device-based systems, their clinical use and application.
  • Establish and advocate for best practices and continuous improvement as to mature Product Engineering and associated processes (Center of Excellence).
  • Champion consistent implementation of the Quality System across projects

QUALIFICATIONS

  • The candidate should be familiar with a range of systems engineering methods and tools, with demonstrated proficiency. In addition to strong systems engineering skills and experience, they must be comfortable dealing with ambiguity, and be confident in applying engineering experience to make or facilitate teams through pragmatic choices throughout product development.
  • The candidate must be a self-starter, have a strong work ethic, and have a track record of driving initiatives to achieve objectives. Experience as a creative problem solver, passion for continuous improvement, creativity, and having the ability to work autonomously and within a team setting are all required attributes.
  • In support of the above, the candidate must demonstrate excellent oral and written skills with the ability to interface with a variety of disciplines.

BASIC QUALIFICATIONS:

  • Education - Bachelor of Science Degree in Engineering
  • Experience - 4+ years of job-related experience with a bachelor's degree; or 2+ years of job-related experience with a master's degree.

DESIRED/PREFERRED QUALIFICATIONS:

  • Bachelor's or master's degree in Systems Engineering, Packaging Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering.
  • Experience working in cross-functional team effort.
  • Proven ability to accomplish critical project level objectives in a team environment.
  • Knowledge of or experience working in a regulated and/or FDA medical device environment. Knowledge of or experience working with ISO and Quality System Regulation requirements.


Posted: July 16, 2020, 7:12 am
Category : Firmware Engineer
Job Type : Contract
Id : 7798
Region : Twin Cities

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

 

Responsibilities:

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

 

Requirements:

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

 

Desired Experience:

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

 

 



Posted: July 15, 2020, 12:03 pm
Category : R&D Engineer
Job Type : Contract
Id : 7941
Region : Twin Cities

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

Position Responsibilities:

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

Position Requirements:

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


Posted: July 14, 2020, 11:42 am
Category : Reliability Engineer
Job Type : Contract
Id : 7936
Region : Twin Cities

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

  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: July 9, 2020, 9:00 am
Category : R&D Engineer
Job Type : Contract
Id : 7932
Region : Twin Cities

Seeking an Associate Process Engineer to assist engineers in setting up and conducting R&D development experiments and tests. He or she should be hands on in setting up experimental benchtops include setting up electrical dataloggers, sensors, pumps and actuators. The candidate should have basic mechanical knowlede so that they can setup the fluid circuit on the bench.

This position supports the development of water purification subunit to be used in a medical device application. The majority of time will be spent in laboratory preparing and testing water purification unit and functional component & sub-components. This position works under supervision of more experienced engineers and follows established procedures.

Main Responsibilities and Tasks:

  • Preparation of aqueous solutions, using standard laboratory equipment and techniques to handle solutions
  • Perform routine measurements and perform routine equipment calibrations as required
  • Set-up and operate testing equipment including data acquisition software
  • Collect and prepare samples for analysis; perform sample analyses using established procedures
  • Ability to maintain focus and attention to detail in setting up, executing and documenting chemical/analytical tests.
  • Proficiency with Microsoft Excel to perform data entry, modest data analysis such as basic graphs and summary statistics, and ability to format data as requested for export to other programs.
  • Proficient with standard test and measurement equipment, such as thermocouples and RTDs, pressure transducers, flow meters, conductivity cells, pH sensors, weight scales, and calipers.
  • Proficiency with Microsoft PowerPoint to create simple diagrams, figures, and schematics to document work performed. Basic familiarity with collecting data using Labview software.
  • Characterization of materials and functional sub-components using established testing methods
  • Development and optimization of chemical processes and associated test methods under the direction of engineers and scientists

Required Qualifications & Experiences:

  • BA/BS in Chemistry, Chemical Engineering or equivalent


Posted: July 1, 2020, 1:31 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7930
Region : Twin Cities

Looking for a Senior Firmware Engineer to join our R&D Organization to design and develop new and modifications to firmware for the cardiac ablation systems. The Senior Firmware Engineer will also be responsible for designing test systems or subsystems for testing the equipment. 

Areas of responsibilities will include firmware system design, software development in C, design requirements, test requirements and test procedures, PC-based simulation and test automation in C#.Candidates must be able to translate design inputs into firmware design, write detailed firmware specifications, generate and review design documentation, interface specifications, test specifications and test reports in compliance with design control procedures used within the medical device industry.  Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

CVG, Cardiac Ablation Solutions seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.

 

POSITION RESPONSIBILITIES

  • The candidate must have the ability to work well with a variety of individuals ranging from various engineering disciplines (mechanical, electrical, and software) to marketing, clinical, reliability, regulatory and operations.
  • Design, develop, test, document, operate and maintain software and firmware components and computing systems software to be applied to and integrated with mechanical and electrical systems.
  • Applies the appropriate standards, processes, procedures and tools throughout the system development life cycle to support the generation of such engineering applications and wide range of products.
  • Support Manufacturing in troubleshooting operations involving medical devices through assembly and test
  • Research and implement new technologies to enhance product features, improve reliability, and lower cost
  • Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing
  • Work in an Agile environment as part of team, in consultation with Engineering Management

 

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 8+ years of embedded software design and development with Bachelors Degree in Engineering (Electrical or Software)
  • 6+ years of experience with Masters Degree or
  • 5+ years of experience with PhD
  • Embedded software development in C language
  • Strong experience working with hardware, including ability to read schematics, data sheets and interface specifications
  • Strong experience in technical specification and report writing
  • Must be able to mentor and review the work of less experienced engineers
  • Must be able to work with minimal supervision
  • Mastery of basic laboratory instruments and tools (e.g. DMM, oscilloscope, logic analyzer, spectrum analyzer)
  • Ability to work in a team environment; strong collaboration skills
  • Effective verbal and written communication

 

DESIRED/PREFERRED QUALIFICATIONS

  • MS Software Engineering or Electrical Engineering
  • Experience with cardiac ablation products
  • Experience with ARM Cortex M processors (preferably STMicro)
  • Experience with real-time operating system (e.g. µC/OS-II, FreeRTOS)
  • Experience with IAR Embedded Workbench
  • Experience with TCP/IP communication and lwIP
  • Experience with Unity unit test framework
  • Experience with C#
  • Experience with embedded security (e.g. Secure boot, Chain of Trust, Authentication, etc.)
  • Specific knowledge of international medical device standards


Posted: June 26, 2020, 6:51 am
Category : Packaging Engineer
Job Type : Contract
Id : 7927
Region : Twin Cities

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

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


Posted: June 23, 2020, 11:13 am
Category : Systems Engineer
Job Type : Contract
Id : 7922
Region : Twin Cities

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

POSITION RESPONSIBILITIES:

  • Typically an individual contributor with responsibility in a professional discipline or specialty.
  • Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
  • May act as a mentor to colleagues or may direct the work of other lower level professionals.
  • The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
  • Recognized expert, managing large projects or processes.
  • Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.
  • Coaches, reviews and delegates work to lower level specialists.
  • Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
  • May manage large projects or processes that span outside of immediate job area.
  • Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.
  • Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
  • Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
  • May negotiate with others to reach understanding or agreement, and influence decision making.
  • Typically provides guidance, coaching and training to other employees within job area.
  • Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience:

  • Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
  • May have broad knowledge of project management.
  • Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: June 15, 2020, 12:29 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7856
Region : Twin Cities

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

 

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

 

Preferred Skills:

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

 

Posted: February 28, 2020, 1:47 pm
Category : 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 : 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 : 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.

 

Requirements:

  • 3+ yeas of leading product design development.
  • 7+ years of direct experience with the product development process ranging from requirements development, prototyping, verification and product release.
  • Experience in medical device design or other regulated industries
  • 7+ years of leading/contributing completion of DHF document deliverables.
  • 7+ years of working in development of devices regulated under IEC 60601-1 standard
  • 3+ years working under ISO 14971 Risk Management for Medical Device Standard

 

Strong Candidate in addition to requirements:

  • 3+ years of planning, assigning, and directing work
  • Responsible appraising performance
  • 3+ years in contract manufacturing environment

 

Duties and Responsibilities:

  • Strong analytical and problem solving background.
  • Works with suppliers and manufacturing facilities to design for manufacturability.
  • Identifies and efficiently resolves technical problems and issue.
  • 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.
  • Delegates and sets work direction for technicians and designers.
  • Creates test protocols and reports for verification testing.
  • Proficient in CAD (Solidworks preferred), Labview and general test and measurement equipment preferred.
  • Able to complete engineering tasks in a timely fashion, and manage time budgets for tasks.
  • Effectively communicates project technical status, time and schedule for tasks including estimates to complete.
  • Proficient with documentation control and change order process.

 



Posted: May 14, 2019, 11:46 am
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