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Medical Device Risk Management Jobs in Minnesota

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Medical device assembler HIRING!! (AO26)

Saint Paul, MN · On-site

$18 - $19.25/hr

Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals ... Previous medical device, manufacturing, or assembly experience is helpful * High school degree or ...

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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.

Senior Software Business Analyst - Medical Device (Hybrid - Maple Grove, MN) - Contract

Maple Grove, MN • On-site

Pharmavise
IT Services • 11 - 50 employees
Learn more about Pharmaviseexternal

$94K - $122K/yr

Contractor

Re-posted 10 days ago

Job description


Our Fortune 500 Medical Device client has an exciting opportunity for a Senior Software Business Analyst.
Job Summary:
We are seeking an experienced Senior Software Business Analyst to join our dynamic team in the medical device industry. This role is critical to bridging the gap between clinical users, business stakeholders, and software development teams. The ideal candidate will possess strong analytical skills, in-depth knowledge of software development practices, and a deep understanding of regulatory and compliance requirements specific to healthcare and medical device software (e.g., FDA, ISO 13485, IEC 62304).
Responsibilities:
• Collaborate with cross-functional teams including product managers, engineers, QA, regulatory, and clinical experts to define software requirements for medical device products.
• Elicit, document, and manage business and functional requirements using industry-standard techniques (e.g., user stories, use cases, process flows).
• Translate complex clinical and business needs into detailed software requirements specifications (SRS).
• Act as the primary liaison between business stakeholders and development teams throughout the product lifecycle.
• Ensure software solutions align with regulatory standards and risk management processes (e.g., design control, traceability, usability).
• Support software validation and verification efforts by reviewing test plans and ensuring requirements coverage.
• Contribute to continuous improvement initiatives within the software development and requirements management processes.
• Facilitate requirement change management processes and impact analysis.
• Participate in audits and regulatory submissions as needed.
Qualifications:
• Bachelor's or Master's degree in Business, Engineering, Computer Science, Biomedical Engineering, or related field.
• 5+ years of experience as a Business Analyst, including at least 2 years in a senior or lead role.
• Proven experience in the medical device industry or regulated healthcare software environment.
• Strong knowledge of IEC 62304, ISO 13485, 21 CFR Part 11, and FDA Design Controls.
• Solid understanding of Agile, Scrum, and/or Waterfall methodologies.
• Proficiency with tools such as Jira, Confluence, Azure DevOps, and requirements management software such as Jama (highly preferred)
• Exceptional communication skills with the ability to convey technical concepts to non-technical stakeholders.
• Strong analytical mindset and attention to detail.
Preferred Qualifications
• Experience with SaMD (Software as a Medical Device) or embedded systems.
• Familiarity with HL7, FHIR, DICOM, or other healthcare interoperability standards.
• Certification such as CBAP, PMI-PBA, or similar is a plus.
Why Join Us?
Work with cutting-edge medical technologies that improve patient outcomes. Collaborate with world-class professionals in a mission-driven organization focused on innovation, compliance, and quality.
Other Details:
• Schedule: 08:00:AM - 04:30:PM CST
• Work Setup: Hybrid at Maple Grove, MN
• Contract Length: 6 Months
• Start Date:9/2/2025

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