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 project analysis
Medtronic UK is seeking a PD Program Manager to oversee released product management for energy-based medical devices, ensuring compliance with various regulatory standards. The role involves technical insights, project execution, risk assessment, and collaboration across teams, requiring strong engineering and regulatory experience
Job Summary
The role involves leading released product management programs while providing technical insights on energy-based medical devices to assess functional impacts.
Candidates must ensure strict adherence to global regulations including FDA QSR, ISO standards, and IEC electrical safety requirements.
The position offers a competitive salary range of $163,000 to $204,000 per year along with comprehensive health and retirement benefits.
Matching Summary
Match Score: 85
Medtronic UK is seeking a PD Program Manager to oversee released product management for energy-based medical devices, ensuring compliance with various regulatory standards. The role involves technical insights, project execution, risk assessment, and collaboration across teams, requiring strong engineering and regulatory experience.
Salary
Base: $163,000 to $204,000 per year; Bonus/Equity: Incentive plans available; Benefits: Health, dental, vision, 401(k) match, stock purchase plan
Skills & Requirements
Must-have
FDA QSR 21 CFR 820 compliance
ISO 13485 risk management
Monte Carlo simulation project analysis
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 activity coordination
Design of Experiments implementation
CAPA process oversight experience
Tolerance stack-up analysis skills
Key Requirements
Bachelor's degree in Engineering or Master's with 2 years experience
Minimum 2 years experience in FDA QSR 21 CFR 820
Certified Six Sigma Black Belt by ASQ or equivalent