Post-Market Reliability Engineer II – Quality & Safety

Regulatory Jobs; Fridley (MN); Presencial; USD 85.000 - 127.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, dental and vision insurance

401(k) plan with employer match

Paid time off

Descripción de la vacante

Medtronic is seeking a Reliability Engineer II for our Rice Creek campus in Fridley, MN. You will lead evaluations of field performance, drive risk analyses, and collaborate with cross-functional teams to improve device reliability and safety.

The role requires a bachelor’s degree with 2+ years of experience or a Master’s with minimal experience. You will work on hardware, firmware, and software systems with limited travel.

Formación

• Bachelor's degree with 2+ years of relevant experience.
• Master's degree with minimal or no required experience.
• Post-market quality or reliability engineering experience preferred.
• Knowledge of ISO 14971 risk management.
• Experience investigating product complaints and CAPA.
• Strong analytical skills using statistical methods.
• Cross-functional collaboration with manufacturing, operations and design teams.
• Ability to interpret hardware, firmware and software performance data.

Responsabilidades

• Lead technical evaluations of field-observed product performance and perform risk assessments.
• Analyze complaint data, software performance, hardware reliability, labeling, and trends for improvements.
• Collaborate with Medical Safety to assess patient harm and evaluate risk.
• Evaluate design, manufacturing, supplier, and software changes for released products.
• Serve as technical lead for post-market quality processes including CAPA.
• Partner cross-functionally to investigate field issues and implement solutions.
• Develop data-driven recommendations to improve reliability and patient safety.
• Support post-market risk evaluations and containment actions when needed.

Conocimientos

Risk assessment

Data analysis

Statistics

Regulatory compliance

Root cause investigation

Communication

Hardware/software data interpretation

Educación

Bachelor's degree

Master's degree

Descripción del empleo

Medtronic is seeking a Reliability Engineer II for our Rice Creek campus in Fridley, MN. You will lead evaluations of field performance, drive risk analyses, and collaborate with cross-functional teams to improve device reliability and safety.

The role requires a bachelor’s degree with 2+ years of experience or a Master’s with minimal experience. You will work on hardware, firmware, and software systems with limited travel.