Neuromodulation And Pelvic Health Team Member
We are currently seeking a professional to join our Neuromodulation and Pelvic Health team to drive and support risk management sustaining activities. This role is based in Minneapolis, MN, a vibrant city known for its rich cultural scene and diverse community. Enjoy the benefit of working remotely on Fridays while being part of an innovative team.
Responsibilities
- 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 the impact of potential issues on patient safety and product performance.
- Perform and document Risk Reviews to communicate the 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.
Must Have
- Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.
- 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 in the application of statistics.
- Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.
- Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).
- Experience with implantable medical devices.
- Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.
- Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.
Nice To Have
- A self-motivated learner who actively seeks out new knowledge, skills, and solutions to adapt to evolving challenges.
- Experience with data analytics.