Medical Device Systems Designer

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 responsibilitiesRefine 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 protocolsRequired qualifications5+ 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