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Medical Device Risk Management Jobs in Minneapolis, MN

Elucent Medical

Systems Test Engineer

Eden Prairie, MN · On-site

$65K - $75K/yr

Exposure to medical device design controls, verification and validation, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, requirements traceability, risk management or regulated product development.

Children's Minnesota

Risk Manager

Minneapolis, MN · On-site

Position Summary This position has organizational wide management responsibilities as a key risk ... This role will also be responsible for assisting with medical device recall, environment of care ...

Children's Minnesota

Risk Manager

Minneapolis, MN · On-site

Position Summary This position has organizational wide management responsibilities as a key risk ... This role will also be responsible for assisting with medical device recall, environment of care ...

Children's Minnesota

Risk Manager

Minneapolis, MN · On-site

Position Summary This position has organizational wide management responsibilities as a key risk ... This role will also be responsible for assisting with medical device recall, environment of care ...

Stereotaxis

Project Manager

Minneapolis, MN · On-site

... and risk management activities. Manage technical partners/ vendors supporting product development activities. Ensure all projects comply with FDA, ISO 13485, and other relevant medical device ...

Childrens Health Care

Risk Manager

Minneapolis, MN

Position Summary This position has organizational wide management responsibilities as a key risk ... This role will also be responsible for assisting with medical device recall, environment of care ...

Veranex

Sr Design Assurance Engineer

Minneapolis, MN · On-site

$93K - $133K/yr

Lead risk management for novel and existing medical devices, including risk management plans and ... device/equipment categories. * Supports internal and external audit activities. * Trains and ...

Medtronic

Sr. Software Systems Engineer

Fridley, MN · On-site

... risk management, verification and validation, and regulatory expectations for medical device development. Key Responsibilities * Provide design quality support for software and software-enabled ...

Medtronic

Sr. Software Systems Engineer

Fridley, MN

... risk management, verification and validation, and regulatory expectations for medical device development. Key Responsibilities * Provide design quality support for software and software-enabled ...

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Showing results 41-60

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Minneapolis, MN

Medical Device Risk Management information

See Minneapolis, MN salary details

$53.8K

$116.4K

$177.4K

How much do medical device risk management jobs pay per year?

As of Aug 14, 2026, the average yearly pay for medical device risk management in Minneapolis, MN is $116,442.00, according to ZipRecruiter salary data. Most workers in this role earn between $93,900.00 and $134,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in medical device risk management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a medical device risk management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.

What are popular job titles related to Medical Device Risk Management jobs in Minneapolis, MN?

For Medical Device Risk Management jobs in Minneapolis, MN, the most frequently searched job titles are:

What job categories do people searching Medical Device Risk Management jobs in Minneapolis, MN look for?

The top searched job categories for Medical Device Risk Management jobs in Minneapolis, MN are:

What cities near Minneapolis, MN are hiring for Medical Device Risk Management jobs?

Cities near Minneapolis, MN with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Minneapolis, MN as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $116,442 per year, or $56 per hour.

Systems Test Engineer

Elucent Medical

Eden Prairie, MN • On-site

$65K - $75K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 21 days ago

Job description

Job Title:
Systems Test Engineer
Department:
Development
Reports to:
Director of Systems and Performance
Work Location:
In Person - Eden Prairie, MN
Pay Range:
$65,000 - $75,000
About Elucent Medical:
Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.
Supervisory Responsibilities:
None.
Job Responsibilities:
  • Develop, maintain, and execute system-level verification and validation test protocols for medical device systems in accordance with approved protocols, acceptance criteria, company SOPs, good documentation practices, and applicable FDA/ISO quality-system requirements.
  • Design and perform challenge testing for complex clinical workflows, edge cases, realistic use conditions, and risk scenarios.
  • Review requirements, user needs, risk controls, and intended-use scenarios to support test coverage, acceptance criteria, and traceability.
  • Verify software changes, defects, and work items using Azure DevOps or similar lifecycle management tools; document findings, verification evidence, unresolved anomalies and investigation results in appropriate records.
  • Identify, document, investigate, and escalate anomalies, test deviations, nonconforming results, usability issues, workflow gaps, performance concerns, and unexpected system behavior.
  • Troubleshoot and resolve system interactions involving software, hardware, RF environments, and instrumentation.
  • Use scripts, Python-based tools, automation, and data-analysis workflows to support testing, investigations, and engineering decisions.
  • Execute testing in accordance with approved procedures, quality-system requirements, applicable standards, and good documentation practices.
  • Collaborate with systems, software, electrical, mechanical, quality, regulatory, clinical, manufacturing, and leadership personnel through design reviews, risk reviews, requirements reviews, defect reviews, and software change reviews.
  • Support innovation efforts through prototype evaluation, data analysis, exploratory testing, and technical feedback sessions to improve and expand the product portfolio.
  • Support manufacturing, field service, and post-market investigations as assigned.

Qualifications
Education and Experience:
  • Required: Bachelor's degree in Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Computer Science, Physics, Mathematics, or a related technical field.
  • Required: 0-2 years of relevant engineering, test, verification/validation, quality, software, hardware experience.
  • Required: Ability to follow approved procedures, document objective evidence, apply good documentation practices, and escalate quality, safety, regulatory or technical concerns.
  • Preferred: Experience working with complex systems involving software, hardware, electrical, mechanical, user interface, and human factors.
  • Preferred: Experience developing and executing test protocols, engineering studies, and verification activities.
  • Preferred: Experience verifying software changes and documenting defects using Azure DevOps or a similar lifecycle management tool.
  • Preferred: Experience with data collection, analysis, scripting, automation, laboratory instrumentation, test fixtures, or data acquisition systems.
  • Preferred: navigation, imaging, or other medical device experience with exposure to design verification and validation, risk management, or requirements traceability.
  • Preferred: Exposure to medical device design controls, verification and validation, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, requirements traceability, risk management or regulated product development.

Required Skills/Abilities:
  • Ability to perform assigned testing in accordance with FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, company SOPs, good documentation practices, and approved test procedures.
  • Strong analytical, systems-thinking, and problem-solving skills.
  • Ability to understand interactions between software, hardware, electrical, mechanical, user interface, and clinical use elements.
  • Ability to design, execute, troubleshoot, and document system-level engineering tests.
  • Strong documentation skills, including protocols, reports, engineering summaries, defect documentation, and verification evidence, and traceability records.
  • Ability to interpret requirements, user needs, risk controls, intended-use scenarios, and design inputs.
  • Ability to verify software changes, document findings, analyze test data, identify trends, and communicate technical conclusions.
  • Ability to use or develop scripts, automation tools, data-analysis utilities, or engineering tools; Python experience preferred.
  • Ability to support prototype evaluation, test-method development, technical exploration, and innovation activities in addition to formal verification and validation work.
  • Ability to work independently with general direction, collaborate cross-functionally, prioritize assigned work, follow quality-system procedures, and escalate risks appropriately.

Physical Requirements / Work Conditions:
  • Ability to work in office and laboratory environments.
  • Frequent use of computers, software tools, laboratory instrumentation, test equipment, fixtures, data-acquisition systems, and standard office equipment.
  • Ability to perform hands-on testing, including setup, operation, and troubleshooting.
  • Ability to sit, stand, walk, bend, reach, and perform bench-level engineering work for extended periods as needed.
  • May require occasional lifting, carrying, pushing, or pulling of equipment, fixtures, materials, or test components up to 25 pounds.

Elucent Medical Benefits, Culture and Work Environment
At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.
Fulltime Employees are provided:
  • 401(k)
  • 401(k) matching (4%)
  • Dental insurance
  • Health insurance
  • Vision insurance
  • Paid Holidays
  • Paid Vacation Days
  • Paid Sick Days
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Pet Insurance
  • Employee Assistance Programs

Affirmative Action / EEO Statement
Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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