Medical Device System Designer

Job Summary

To support the development of medical devices, the fully remote Systems Designer will manage design controls, regulatory compliance, and documentation processes while collaborating with cross-functional teams over a 6-month contract.

Key responsibilities

• Refine existing documentation and ensure regulatory alignment for new and existing medical device products
• Draft and maintain design history file (DHF) content, including user needs, design inputs, and risk documentation
• Support risk analysis and contribute to usability planning and design mitigations within a regulatory environment

Required qualifications

• 5+ years of experience in medical device design and regulatory compliance
• Strong experience with Software as a Medical Device (SaMD) and design controls
• Familiarity with ISO 14971 and IEC 62366 standards
• Proficient in drafting DHF content and supporting V&V protocol development
• Experience with tools such as Codebeamer and Jira