Product Development Engineer
Stark Pharma Solutions Inc · Salt Lake City, UT · 2 wk ago
On-siteEngineeringFull-time
Key Responsibilities
- Develop and maintain Design History File (DHF) documentation, including user needs, design inputs, system requirements, traceability matrices, and risk management files.
- Define clear, complete, and testable system requirements while maintaining end-to-end traceability.
- Support risk management activities, including FMEA and risk documentation in accordance with ISO 14971.
- Participate in Verification & Validation (V&V) activities by developing test protocols, executing test cases, and documenting results.
- Collaborate with Engineering, Quality Assurance, Clinical, and Regulatory teams to support product development activities.
- Ensure compliance with FDA Quality Management System (QMS) requirements and applicable regulatory standards.
- Support usability engineering activities following IEC 62366 guidelines.
- Utilize Codebeamer, JIRA, or similar requirements management and traceability tools.
- Contribute to continuous improvement initiatives throughout the product development lifecycle.
Required Qualifications
- Bachelor's degree in Engineering or a related scientific discipline (Biomedical Engineering preferred).
- 5+ years of experience in Product Development, Systems Design, or related engineering roles within a regulated environment.
- Hands-on experience supporting Software as a Medical Device (SaMD) development.
- Strong experience creating and maintaining Design History File (DHF) documentation, including user needs, requirements, traceability matrices, and risk files.
- Working knowledge of ISO 14971; familiarity with ISO 62304 and IEC 62366.
- Experience working within FDA Quality Management System (QMS) requirements.
- Experience using Codebeamer, JIRA, or similar requirements management and traceability tools.
- Experience supporting Verification & Validation (V&V) activities.
- Strong analytical, technical, documentation, written, and verbal communication skills.
- Ability to collaborate effectively with multidisciplinary and cross-functional teams.