Systems Design Engineer (SaMD)

Job Summary

To support the development and lifecycle management of a Software as a Medical Device (SaMD) product, the contract Systems Design Engineer (SaMD) will work remotely during Mountain Time business hours, focusing on systems engineering activities, Design History File (DHF) documentation, requirements development, and risk management within a regulated medical device environment.

Key responsibilities

• Develop and maintain Design History File (DHF) documentation, including user needs and system requirements
• Participate in risk management activities and support usability engineering in accordance with medical device standards
• Collaborate with cross-functional teams to ensure product quality and regulatory compliance throughout the development lifecycle

Required qualifications

• Bachelor's degree in Engineering or a related scientific discipline; Biomedical Engineering preferred
• Minimum of five years of experience in systems design or product development within a multidisciplinary organization
• Experience supporting Software as a Medical Device (SaMD) development and maintaining Design History File (DHF) documentation
• Working knowledge of ISO 14971 and familiarity with IEC 62304 and IEC 62366
• Proficiency with requirements management and traceability tools such as Codebeamer or JIRA