Risk Management Engineer

Actalent; Saint Paul (MN); On-site; USD 96,000 - 117,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k)

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Job summary

Actalent in Saint Paul, MN is seeking a Risk Management Engineer to lead risk management across the product lifecycle for medical devices. You will develop risk management plans, perform hazard analyses, and ensure risk controls are verified.

You will integrate cybersecurity risk considerations and drive improvements within cross-functional teams. The role requires 5–10+ years in risk management, DFMEA/PFMEA/SWFMEA experience, and strong documentation skills.

Qualifications

• Bachelor's degree in engineering or 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.

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 document DFMEA, PFMEA, UFMEA, CFMEA, and SWFMEA.
• Perform and document formal hazard analyses to support risk management activities.
• Ensure traceability between hazards, risk assessments, risk controls, and verification activities.
• Monitor post-market surveillance data and customer complaints for emerging risks.
• Update risk management files and conduct annual risk reviews.
• Support CAPA activities with risk-based decision-making.
• Own and drive the overall risk strategy across multiple product platforms.
• Integrate cybersecurity risk considerations into patient safety assessments and frameworks.
• Drive process improvements to risk management practices and tools.
• Collaborate with design assurance and systems engineering to embed robust risk management.

Skills

Risk management

FMEA expertise

Systems engineering

Regulatory compliance

Cybersecurity risk integration

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Tools

FMEA software

Risk management tools

Traceability systems

Job description

Job Title: Risk Management Engineer

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.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

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

Application Deadline

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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristi s protected by law.

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

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.