Reliability Engineer II - NMPH - Fridley, MN (Onsite)
About The Position
This role is based onsite at our Rice Creek campus in Fridley, Minnesota, where teams collaborate to accelerate innovation and put patients first. The position requires less than 10% travel to support cross-functional collaboration and project execution. As a Reliability Engineer II, you will play a critical role in ensuring the continued safety, reliability, and performance of our market-released medical devices. You will serve as a technical leader responsible for evaluating real-world product performance, identifying emerging risks, and driving continuous product improvements across hardware, firmware, and software systems. You will be working closely with engineering, manufacturing, medical safety, regulatory, and quality teams, you will transform field data into actionable insights that influence product enhancements, strengthen risk management strategies, and reinforce the trust that patients and clinicians place in our therapies every day.
Requirements
- Requires a Baccalaureate degree and minimum of 2 years of relevant experience, OR Master’s degree with a minimum of 0 years of relevant experience.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- The employee is regularly required to be independently mobile.
- The employee is also required to interact with a computer, and communicate with peers and co-workers.
- Applicants must be authorized to work in the country of employment without sponsorship.
Nice To Haves
- Experience supporting post-market quality, reliability engineering, or product performance for regulated medical devices.
- Knowledge of medical device risk management methodologies, including ISO 14971.
- Experience investigating product complaints, field issues, and CAPA activities.
- Strong analytical skills with experience using statistical methods to evaluate product reliability and performance trends.
- Experience partnering with manufacturing, operations, supplier quality, or design engineering teams to implement product improvements.
- Ability to interpret hardware, firmware, and software performance data to support technical investigations.
- Experience authoring technical reports, engineering assessments, and documentation within a regulated environment.
- Strong cross-functional collaboration, communication, and technical influence skills.
- Demonstrated ability to make sound engineering decisions using data, risk analysis, and customer feedback.
Responsibilities
- Lead technical evaluations of field-observed product performance, performing risk assessments aligned with product risk management files and existing mitigations.
- Analyze complaint data, software performance, hardware reliability, labeling considerations, and product trends to identify opportunities for improvement.
- Partner with Medical Safety to assess potential patient harm, estimate occurrence probabilities, and evaluate overall product risk.
- Evaluate the reliability and risk impact of design, manufacturing, supplier, and software changes for commercially released products.
- Serve as the technical representative for post-market quality processes, including Corrective and Preventive Actions (CAPA).
- Collaborate cross-functionally with R&D, Manufacturing, Quality, Regulatory Affairs, and Medical Safety to investigate field issues and implement effective solutions.
- Develop data-driven recommendations that improve product reliability, patient safety, and long-term product performance.
- Support post-market risk evaluations and decision-making related to containment actions, product corrections, field actions, recalls, and labeling updates when necessary.
- Help shape and continuously improve post-market reliability strategies, processes, and risk management practices.
Benefits
- Competitive Salary and flexible Benefits Package
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
