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Medical Device Risk Management Jobs in Minnesota

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 ...

DivIHN

Senior Systems Engineer (Medical Device)

Plymouth, MN · On-site

$109K - $149K/yr

Senior Systems Engineer (Medical Device) Duration: 12 Months Location: Plymouth, MN Only W2 ... risk management, system integration, verification, and validation of medical devices. What you'll ...

Children's Minnesota

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 ...

Childrens Health Care

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 ...

Abbott

Development Quality Engineer II

Plymouth, MN · On-site

$35 - $38/hr

Seeking a Quality Engineer with experience in medical device product development to support risk management, design controls, verification and validation, and regulatory compliance for electro ...

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Medical Device Risk Management information

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 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 job categories do people searching Medical Device Risk Management jobs in Minnesota look for?

The top searched job categories for Medical Device Risk Management jobs in Minnesota are:

What cities in Minnesota are hiring for Medical Device Risk Management jobs?

Cities in Minnesota 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 Minnesota as of September 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 67% In-person, and 33% Hybrid job distribution.

Product Development Engineer III

Saint Paul, MN • On-site

Forj Medical
See more jobs at Forj Medicalexternal

Full-time

Medical, Dental, Vision, Retirement

Re-posted 11 days ago

Key responsibilities

  • Lead the design, development, and optimization of Medical Device & Surgical Navigation products from concept through commercialization.

  • Coordinate prototyping, testing, and analysis activities to assess product performance and reliability.

  • Collaborate with cross-functional teams to support design transfer, manufacturing readiness, and product launch activities.

Job description

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.
Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.
Job Summary:
Product Development Engineer III applies advanced engineering principles and medical device product development expertise to develop and support Surgical Navigation products from concept through commercialization. This role is responsible for planning and executing engineering activities within our product development process, including design documentation, verification and validation, prototype and production-intent builds, and cross-functional project execution.
This role works independently on complex technical assignments and collaborates with both our external customers and internal Quality, Regulatory, Operations, Commercial Team and Supply Chain teams to ensure product requirements are met while maintaining compliance with design control and quality system requirements. It requires strong technical judgment, problem-solving skills, and the ability to drive project deliverables with limited supervision.
Job Duties and Responsibilities:
Product Development
  • Lead the design, development, and optimization of Medical Device & Surgical Navigation products, components, assemblies, and subsystems from concept through commercialization.
  • Translate customer, user, and clinical needs into product requirements, engineering specifications, and design inputs.
  • Perform concept development, feasibility assessments, risk analyses, and design reviews.
  • Coordinate prototyping, testing, and analysis activities to assess product performance and reliability.
  • Evaluate design alternatives and implement solutions that optimize performance, reliability, manufacturability, and usability.
  • Troubleshoot complex technical challenges and drive effective resolutions.
  • Support Voice of Customer (VOC) activities and apply market and clinical insights to product development.
  • Ensure compliance with applicable medical device regulations, design controls, risk management processes, and quality system requirements.

Engineering Documentation
  • Create and maintain engineering documentation including CAD models, drawings, GD&T specifications, BOMs, product specifications, test protocols, test reports, and DHF deliverables.
  • Ensure documentation is complete, accurate, and compliant with quality system requirements.
  • Support design verification and validation activities through timely and thorough documentation.

Design Verification & Validation
  • Develop and execute verification and validation strategies, plans, protocols, and reports.
  • Define test methods, acceptance criteria, and data collection approaches to demonstrate compliance with product requirements.
  • Analyze test results, resolve identified issues, and present findings during technical and design reviews.

Verification & Validation Builds
  • Coordinate prototype, engineering, and production-intent builds.
  • Partner with Operations, Manufacturing Engineering, Supply Chain, and Quality to ensure build readiness and successful execution.
  • Track build outcomes, document findings, and drive issue resolution.

Cross-Functional Collaboration
  • Collaborate with Quality, Regulatory, Clinical, Marketing, Manufacturing, Supply Chain, Program Management, and Operations teams to achieve project objectives.
  • Support design transfer, manufacturing readiness, and product launch activities.
  • Communicate project status, technical risks, and mitigation plans to stakeholders.

Contribute to continuous improvement initiatives that enhance product quality and development efficiency
Qualifications
Required
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
  • 5+ years of product development experience, preferably in the medical device industry.
  • Experience developing mechanical and/or electromechanical products in a regulated environment.
  • Strong knowledge of design controls, risk management, and regulated product development processes.
  • Expertise in product design, DFx, materials selection, manufacturing processes, and mechanical problem-solving.
  • Experience creating engineering documentation, including drawings, specifications, BOMs, DHF deliverables, and verification/validation documentation.
  • Proficiency with SolidWorks or similar 3D CAD software, including GD&T and engineering drawing creation.
  • Experience with prototyping, verification and validation testing, root-cause analysis, and technical troubleshooting.
  • Strong technical writing, analytical, and problem-solving skills.
  • Proficiency with Microsoft Office Suite.
  • Ability to independently manage technical work and collaborate effectively within cross-functional teams.
  • Experience supporting FDA submissions, including 510(k) and/or PMA programs.

Preferred
  • Experience developing Surgical Navigation, image-guided surgery, or capital medical equipment products.
  • Medical device manufacturing experience.
  • Knowledge of FDA QSR, ISO 13485, IEC 60601, and other applicable medical device standards.
  • Experience supporting design transfer and manufacturing readiness.
  • Experience with machine shop operations, injection molding, and additive manufacturing.
  • Familiarity with requirements management, FMEA, statistical analysis, Microsoft Project, and Minitab.

Salary: $85,000-$115,000
EEO Statement
Forj 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.
Employment Requirement
Must be authorized to work in the United States.
Compensation and Total Rewards Package
The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.

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