Pd Program Manager

Medtronic Diabetes

Base: $163,000 to $204,000 py; bonus/equity: incen...
Not specified
Fda qsr 21 cfr 820 compliance
Iso 13485 risk management
Monte carlo simulation for project risks
Medtronic Diabetes is seeking a Program Manager to lead released product management and sustainment programs, focusing on energy-based products and ensuring compliance with industry regulations. The ideal candidate will have a strong engineering background, particularly in mechanical, industrial, or biomedical engineering, and experience with FDA regulations and quality management systems

Job Summary

  • This role leads released product management and sustainment programs while providing technical insights on energy-based medical devices.
  • The position requires strict adherence to global regulations including FDA QSR, ISO standards, and IEC safety guidelines.
  • Candidates must possess a Six Sigma Black Belt certification and have experience with Cerebrospinal Fluid products.

Matching Summary

Match Score: 85

Medtronic Diabetes is seeking a Program Manager to lead released product management and sustainment programs, focusing on energy-based products and ensuring compliance with industry regulations. The ideal candidate will have a strong engineering background, particularly in mechanical, industrial, or biomedical engineering, and experience with FDA regulations and quality management systems.

Salary

Base: $163,000 to $204,000 per year; Bonus/Equity: Incentive plans available; Benefits: Health, Dental, Vision, 401(k) match, Tuition assistance

Skills & Requirements

Must-have

  • FDA QSR 21 CFR 820 compliance
  • ISO 13485 risk management
  • Monte Carlo simulation for project risks
  • SAP S/4HANA and HP ALM usage
  • IQ/OQ/PQ validation protocols
  • Injection molding and CNC machining design
  • PTC Creo and SolidWorks CAD tools

Nice-to-have

  • Cross-cultural team collaboration
  • Voice of Customer (VOC) activities
  • Design of Experiments (DOE) implementation
  • CAPA and NCMR process oversight
  • International supplier coordination

Key Requirements

  • Bachelor's degree in Engineering or Master's with 2 years experience
  • Minimum 2 years experience in FDA QSR 21 CFR 820 and ISO 13485
  • Certified Six Sigma Black Belt by ASQ or equivalent
  • Experience with SAP S/4HANA, SAP ECC, and HP ALM
  • Knowledge of IQ, OQ, PQ validation processes
  • Proficiency in PTC Creo, Minitab, SolidWorks, and AutoCAD

Work Rights

Not specified

Tailored Resume

Cover Letter