Risk Management Engineer

Job Title: Risk Management Engineer

Job Description

The Risk Management Engineer supports and leads risk management activities across the entire product lifecycle, from initial concept through obsolescence. This role develops and maintains comprehensive risk management plans, drives hazard analyses and risk assessments, and ensures that risk controls are effectively implemented and verified. The engineer plays a key role in integrating cybersecurity considerations into patient safety assessments and in continuously improving risk management processes for medical devices.

Responsibilities

• Develop, maintain, and continuously improve risk management plans for products from concept through obsolescence.
• Lead or support hazard analyses and risk assessments to identify, evaluate, and control risks associated with medical devices.
• Facilitate and thoroughly document Design FMEA (DFMEA), Process FMEA (PFMEA), Use FMEA (UFMEA), Component FMEA (CFMEA), and Software FMEA (SWFMEA).
• Perform and document formal hazard analyses (HA) to support overall risk management activities.
• Ensure clear and complete traceability between hazards, risk assessments, risk controls, and verification activities throughout the product lifecycle.
• Monitor post-market surveillance data and customer complaints to identify emerging risks and trends.
• Update risk management files and conduct annual risk reviews to maintain accurate and current documentation.
• Support Corrective and Preventive Action (CAPA) activities that have risk management implications, ensuring appropriate risk-based decision-making.
• Own and drive the overall risk strategy across multiple product platforms, aligning risk activities with business and regulatory expectations.
• Integrate cybersecurity risk considerations into patient safety assessments and overall risk management frameworks.
• Drive process improvements to risk management practices, including enhancements to procedures, tools, and updates to risk files.
• Collaborate with design assurance, systems engineering, and cross-functional teams to embed robust risk management into product development and lifecycle processes.

Essential Skills

• Bachelor's degree in engineering or a closely related technical discipline.
• 5–10+ years of experience in risk management or related functions within a technical or medical device environment.
• Proven experience in design assurance, with experience supporting product quality and compliance.
• Systems engineering experience, with the ability to understand complex, integrated product architectures.
• Deep expertise in ISO standards relevant to risk management and medical devices.
• Advanced skills in Failure Modes and Effects Analysis (FMEA), including DFMEA, PFMEA, UFMEA, CFMEA, and SWFMEA.
• Demonstrated experience in product lifecycle ownership, managing risk activities from concept through obsolescence.

Additional Skills & Qualifications

• Experience working with medical devices and related regulatory requirements.
• Strong analytical and problem-solving skills for identifying, assessing, and mitigating risks.
• Ability to interpret and apply post-market surveillance data and complaint trends to risk management decisions.
• Experience contributing to CAPA activities and risk-based decision-making.
• Strong documentation and communication skills for preparing clear, traceable risk management records.
• Proven ability to collaborate effectively with cross-functional teams and influence risk strategy across product platforms.

Work Environment

This role operates in a professional engineering and design assurance environment focused on medical device development and lifecycle management. The Risk Management Engineer collaborates closely with systems engineering, design assurance, and cross-functional teams, working with structured risk management tools and documentation systems. Work typically follows standard business hours, with flexibility as needed to support project timelines and reviews. The environment emphasizes regulatory compliance, patient safety, and continuous improvement in risk management processes, with a professional dress code appropriate for an office and technical setting.

This is a Contract position based out of Saint Paul, MN.

The pay range for this position is $70.00 - $85.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Saint Paul,MN.

This position is anticipated to close on Sep 28, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.