Pd Program Manager

Medtronic, Inc.

Base: $163,000 to $204,000 py; bonus/equity: incen...
Not specified (assumed to be hybrid based on industry norms).
Fda qsr 21 cfr 820 compliance
Iso 13485 risk management
Monte carlo simulation for project risk
Medtronic, Inc. is seeking a Pd Program Manager to lead the management of released product programs, particularly in energy-based medical devices. The role requires a strong engineering background, experience with regulatory compliance, and proficiency in various CAD and project management tools

Job Summary

  • This role leads released product management programs for Medtronic's energy-based medical devices while ensuring strict adherence to global regulatory standards.
  • The position requires utilizing Monte Carlo simulations to quantify risks across the entire project lifecycle and managing system enhancements within SAP environments.
  • Candidates will benefit from comprehensive health insurance, 401(k) matching, and tuition assistance as part of the total compensation package.

Matching Summary

Match Score: 85

Medtronic, Inc. is seeking a Pd Program Manager to lead the management of released product programs, particularly in energy-based medical devices. The role requires a strong engineering background, experience with regulatory compliance, and proficiency in various CAD and project management tools.

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 risk
  • 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-functional international collaboration
  • Voice of Customer (VOC) activities
  • Design of Experiments (DOE) implementation
  • CAPA and NCMR process oversight
  • Tolerance stack-up analysis expertise

Key Requirements

  • Bachelor's degree in Engineering with 5 years experience OR Master's with 2 years
  • Minimum 2 years experience in FDA QSR 21 CFR 820 and ISO 13485
  • Certified Six Sigma Black Belt by ASQ or equivalent
  • Experience with Cerebrospinal Fluid (CSF) products
  • Proficiency in IEC 62366, IEC 60601-1, and EN 62304 regulations

Work Rights

Not specified

Tailored Resume

Cover Letter