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Medical Device Risk Management Jobs (NOW HIRING)

Deegit Inc

QARA

Plymouth, MN · On-site

Experience with ISO 14971 risk management activities * Experience with the post market medical device support (complaint or risk analysis) Skill and Experience Details: Minimum Experience Required:

MSD

Associate Director, Quality Assurance

Rahway, NJ · On-site

... Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and company requirements. This ...

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Medical Device Risk Management information

See salary details

$51.5K

$111.6K

$170K

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

As of Sep 8, 2026, the average yearly pay for medical device risk management in the United States is $111,556.00, according to ZipRecruiter salary data. Most workers in this role earn between $90,000.00 and $129,000.00 per year, depending on experience, location, and employer.

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.

More about Medical Device Risk Management jobs

What cities are hiring for Medical Device Risk Management jobs?

Cities with the most Medical Device Risk Management job openings:

What states have the most Medical Device Risk Management jobs?

States with the most job openings for Medical Device Risk Management jobs include:

What are popular job titles for Medical Device Risk Management?

Popular job titles for Medical Device Risk Management:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $111,556 per year, or $53.6 per hour.

Engineer I, Product Development

Miami, FL • On-site

BioTissue Holdings Inc
See more jobs at BioTissue Holdings Incexternal

$60 - $80/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 7 days ago

Key responsibilities

  • Support design control activities including risk management, verification and validation testing

  • Lead root cause investigations for product failures, customer complaints, nonconformances, CAPAs, and manufacturing issues

  • Design, develop, and implement engineering change requests to improve product performance, manufacturability, quality, reliability, or component availability

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Engineering Miami, FL, US

Salary Range: $68,980.00 To $86,226.00 Annually

About BioTissue & our Culture

At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products. Purpose led us here. Passion and legacy keep us going.

Position Summary

The Engineer I provides product and process engineering support throughout the product’s lifecycle to meet requirements of Good Tissue, Manufacturing and Laboratory Practices (GTP/GMP/GLP). This role primarily contributes to the development and maintenance of medical device Risk Management Files throughout the product lifecycle by ensuring risk management activities and documentation are maintained in compliance with applicable standards and company procedures. This role also focuses on maintaining product quality, reliability, regulatory compliance, and manufacturing efficiency by leading engineering investigations, implementing design changes, resolving technical issues, and driving continuous improvement initiatives. This role collaborates closely with technical services, manufacturing, quality, donor services, regulatory, commercial, medical affairs and external suppliers to ensure uninterrupted product supply while meeting applicable regulatory and quality standards.

  • Support design control activities including risk management, verification and validation testing.
  • Lead root cause investigations for product failures, customer complaints, nonconformances, CAPAs, and manufacturing issues using structured problem-solving methodologies (e.g., DMAIC, Fishbone, 5 Whys)
  • Design, develop, and implement engineering change requests (CRs) to improve product performance, manufacturability, quality, reliability, or component availability.
  • Perform routine testing, data collection, and statistical analysis.
  • Evaluate and qualify alternative materials, components, and suppliers to mitigate supply chain risks.
  • Generate supplier and supply documentation, user requirements specifications, supplier change notification, gap analysis.
  • Maintain Design and Development File (DDF), Medical Device File (MDF), technical documentation, and engineering records in compliance with quality system requirements.
  • Collaborate with cross functional teams to support technology transfer and design transfer activities.
  • Participate in verification and validation testing, including generation and execution of test protocols and reports.
  • Support investigations and documentation of product or process performance issues.
  • Support internal and external audits, including FDA inspections, ISO 13485, and notified body audits.
  • Contribute to continuous improvement initiative and knowledge management to enhance development efficiency.
  • Participate in process improvement projects, including the evaluation and introduction of new equipment, technologies, and tools to improve workflows.
  • Participate in risk assessments (e.g., FMEA, hazard analysis) and establish control strategies consistent with QbD, ICH Q9 and ISO 14971 principles.
  • Maintain Risk Management Files throughout the product lifecycle, including the development, review, and revision of applicable documentation in compliance with ISO 14971.
  • Perform other duties and projects as assigned.
Skills & Abilities
  • Knowledge of cGMP and design controls (e.g., FDA 21 CFR Part 820, Part 210/211, Part 1270/1271, ISO 13485, ICH).
  • Knowledge of medical device risk management principles, including ISO 14971/ISO 13485, risk analysis methodologies, and Risk Management File documentation.
  • Exposure to data analysis software (Minitab, SPSS or similar)
  • Strong organization skills with attention to detail.
  • Effective communicator and eager to learn in a regulated environment.
  • Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional environment.
Education & Experience
  • Bachelor’s degree in biomedical, biotechnology, chemical or related engineering field.
  • 1 or more years of relevant experience in the medical device, biotechnology, or pharmaceutical sector.
Preferred Experience
  • Experience with verification and validation of medical devices.
  • Familiarity with risk management tools (e.g., FMEA, hazard analysis).
  • Familiarity with biocompatibility, sterilization methods, and packaging validation.
  • Experience with technical writing or lab documentation.
Physical Requirements
  • Ability to work in laboratory, office, and cleanroom environments
  • Some travel may be required (<10%)
Total Rewards

At BioTissue, we believe our people are our greatest asset. We offer a comprehensive Total Rewards package designed to support employees' health, financial wellbeing, professional growth, and work-life balance.

Our benefits may include:

  • Medical, Dental, and Vision Insurance
  • Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
  • 401(k) Retirement Savings Plan
  • Company-Paid Basic Life and AD&D Insurance
  • Voluntary Life and AD&D Insurance
  • Short-Term and Long-Term Disability Coverage
  • Employee Assistance Program (EAP)
  • Legal and Identity Protection Benefits
  • Pet Insurance
  • Paid Time Off and Company Holidays
  • Paid Parental and Birthing Leave
  • Family and Medical Leave (FMLA), where applicable
  • Tuition Reimbursement and Professional Development Support
  • Performance-Based Incentive Opportunities
  • Equity or Stock Programs, where applicable

Benefits eligibility and offerings may vary based on position, location, and employment status.

ADA Statement

BioTissue is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the hiring process and employment lifecycle. If you require assistance or accommodation to participate in the application process or perform the essential functions of a position, please contact us to discuss your needs.

Qualified applicants with disabilities will be considered for employment and may be eligible to perform the essential functions of the position with or without reasonable accommodation.

BioTissue is committed to fostering a workplace where everyone feels valued, respected, and empowered to contribute. We welcome applicants from diverse backgrounds and experiences and are proud to be an Equal Opportunity Employer. Employment decisions are based on qualifications, merit, and business needs, without regard to any legally protected characteristic.

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