What are the responsibilities and job description for the SR RELIABILITY ENGINEER (SR RISK ENGINEER) position at Planet Pharma?
Sr Reliability Engineer (Sr Risk Engineer)
Location: Minneapolis, MN
Category: Engineering
Salary: Apply for details
Country: United States
Employment: Contract
Worksite: On-Site
Apply For This Position
Job Description
Can you please confirm your top 3 skills sets required?
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
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.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Location: Minneapolis, MN
Category: Engineering
Salary: Apply for details
Country: United States
Employment: Contract
Worksite: On-Site
Apply For This Position
Job Description
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
- 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.
- Spinal Chord Stimulation, Deep Brain Stimulation, Pelvic Health
- At least 5 years of experience within Medical Device
- As soon as possible
- Targeted starting date: May 4, 2026.
- 4 days a week onsite and 1 day remote
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.
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.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.