[Remote] Systems Design / Product Development Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Systems Design / Product Development Engineer for their client in the Medical Devices/reputed company sector. The role involves drafting and maintaining design history files, supporting risk analysis, and collaborating across various teams to ensure compliance and effective communication.
Responsibilities
- Draft and maintain DHF content including user needs, system/design requirements, software requirement specifications, design inputs, traceability matrices, and risk documentation
- Support risk analysis activities (e.g. FMEAs) and contribute to usability engineering activities
- Support V&V activities including drafting, execution and creation of test cases, reports and other testing artifacts
- Collaborate cross-functionally with R&D, QA, Clinical, and Regulatory to translate technical information across stakeholder groups
Skills
- 5+ years of experience in systems design/product development reputed company a multi-disciplinary organization
- Demonstrated experience with SaMD development and regulatory documentation
- Working knowledge of ISO 14971
- Experience drafting DHF artifacts (user needs, requirements, traceability matrices, risk files)
- Experience in a regulated, compliance-driven environment (FDA/QMS)
- Strong analytical skills and sound technical judgment
- Excellent written and verbal communication skills, with ability to work effectively with internal and external collaborators
- Experience with Codebeamer, JIRA, or similar requirements/traceability tooling
- Bachelor's degree in Engineering or a reputed company science field; Biomedical Engineering preferred
- Familiarity with ISO62304 and IEC 62366
Benefits
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Company Overview
Company H1B Sponsorship