Job Details

Can you please confirm your top 3 skills sets required?

• At least 3 years of experience with ISO 14971 in a medical device company
• At least 3 years of experience creating or maintaining risk management files for medical devices
• At least 3 years of experience working with Quality Design Control deliverables

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• Updating and Maintaining Risk Management Files for Class III Medical Devices
• Working with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
• Collaborating with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.

What products (if any) will this role support?

• Spinal Chord Stimulation, Deep Brain Stimulation, Pelvic Health

What is your target years of experience?

• At least 5 years of experience within Medical Device

When do you plan to start interviewing?

• As soon as possible

Will you be looking to hire and start ASAP or will the start date be delayed? 

• Targeted starting date: May 4, 2026. 

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?

• 4 days a week onsite and 1 day remote

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We are currently looking for a  Sr  Risk Engineer to work within the Neuromodulation and Pelvic Health to drive the and support risk management sustaining activities. 

Location: This position will be a an onsite role  in Fridley, Minnesota with the benefit of working remotely on Fridays.

In this critical role as Sr. Risk Management Engineer, you will work closely with multidisciplinary project teams to create, and remediate risk management documents that meet ISO 14971 . This role is people oriented, requiring excellent collaboration and communication skills; it also requires persnickety attention to detail.

 Responsibilities may include but are not limited to:

·        Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis.

·        Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.

·         Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.

·         Evaluate impact of potential issues to patient safety and product performance

·         Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.

·         Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle.

·         Identify and act upon opportunities for continuous improvement of the Risk Management Process

·         Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance.

·         Create documentation in compliance with applicable procedures to meet project deliverables.

Qualifications 

Experience with implantable medical devices.

Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).

Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).

Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.

Experience in the application of statistics.

Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.

Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.

Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.