Design Controller-medical Devices

GN Audio/Hearing

Glenview, IL, USA
Base: $95,000.00 – 105,000.00; bonus/equity: discr...
Fully remote
Medical device design control
Software development compliance
Iec 62304
Plan and execute Design Control deliverables for Medical Device SW projects in compliance with corporate QMS and regulated standards

Job Summary

  • Plan and execute Design Control deliverables for Medical Device SW projects in compliance with corporate QMS and regulated standards.
  • Write or manage completion of Design Plans, Requirement documents, Design Documents, Risk Assessment and Risk Management File, and other associated documents in compliance with the software development QMS.
  • GN offers a competitive benefits package, including annual bonuses, health insurance, a 401(k) plan, and paid vacation and holidays.

Matching Summary

Plan and execute Design Control deliverables for Medical Device SW projects in compliance with corporate QMS and regulated standards.

Salary

Base: $95,000.00 – 105,000.00; Bonus/Equity: discretionary bonus; Benefits: health insurance, 401(k) plan, paid vacation and holidays

Skills & Requirements

Must-have

  • Medical Device Design Control
  • Software Development Compliance
  • IEC 62304
  • Risk Management File
  • Cross-functional collaboration

Nice-to-have

  • Energetic, self-motivated, innovative
  • MDR experience preferable
  • Aligns with core values

Key Requirements

  • 3+ years in Medical Device Industry
  • BS in Engineering or Sciences
  • Solid understanding of Medical Device Design Control
  • Proficient verbal and written communication skills

Work Rights

Must reside in Chicago, IL or nearby surrounding area

Tailored Resume

Cover Letter