Sr Reliability Engineer

Job Title: SR Reliability Engineer Job ID: 24439 Location: 7000 Central Ave NE, Minneapolis Minnesota 55432 Duration: 8 Months Payrate: $55.00- $60.00/HR. on W2 Additional position details from the manager below: 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 We are currently looking for a Sr Risk Engineer to work within the Client 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. Responsibilities may include the following and other duties may be assigned. Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Created: 2026-04-02