Sr. Manager, Cold Storage Oem

PPD (Thermo Fisher)

Marietta, OH, USA
Onsite
10+ years product development experience
Iso 13485 design control processes
Ult hvac/r temperature-controlled systems
This role leads a multidisciplinary team to manage OEM solutions for cold storage products used in laboratory, clinical, and medical device markets

Job Summary

  • This role leads a multidisciplinary team to manage OEM solutions for cold storage products used in laboratory, clinical, and medical device markets.
  • The position requires strict adherence to ISO 13485 design control processes including risk management, verification, validation, and commercialization activities.
  • Candidates must possess over 10 years of experience developing complex electromechanical systems with a strong preference for refrigeration or thermal systems.

Matching Summary

This role leads a multidisciplinary team to manage OEM solutions for cold storage products used in laboratory, clinical, and medical device markets.

Skills & Requirements

Must-have

  • 10+ years product development experience
  • ISO 13485 design control processes
  • ULT HVAC/R temperature-controlled systems
  • Design History Files (DHF) management
  • UL IEC FDA regulatory standards
  • PLM systems and change management

Nice-to-have

  • Lean PPI continuous improvement methodologies
  • VAVE simulation techniques
  • Global OEM partner collaboration
  • Safety culture fostering
  • Data-driven decision making mindset

Key Requirements

  • Bachelor's degree in engineering discipline
  • Master's degree preferred
  • 3+ years people management experience
  • Experience in regulated product environments
  • Hands-on PLM system experience

Work Rights

Not specified

Tailored Resume

Cover Letter