Note: The job is a remote job and is open to candidates in USA. Accede Solutions Inc is seeking a Systems Design / Product Development Engineer to support the development of a software-based medical device. The ideal candidate will have experience in systems engineering and product development, focusing on regulatory alignment and documentation throughout the product lifecycle.
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 within 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 related science field
- Familiarity with ISO62304 and IEC 62366
- Biomedical Engineering preferred
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