Medical Device Systems Designer

Job Summary

Seeking a Systems Designer for a contract position that is 100% remote, the ideal candidate will manage medical device design controls and product development, ensuring regulatory compliance and documentation for new and existing products.

Key responsibilities

• Refine existing documentation and ensure regulatory alignment for medical devices
• Draft and maintain design history file (DHF) content, including user needs and risk documentation
• Collaborate with cross-functional teams to define testable requirements and support verification and validation protocols

Required qualifications

• 5+ years of experience in medical device design and development
• Strong experience with Software as a Medical Device (SaMD) and design controls
• Familiarity with ISO 14971 and IEC 62366
• Experience in a regulatory environment with strict compliance
• Proficiency with tools such as Codebeamer or Jira