Senior Design Quality Engineer

Position Summary
The Senior Design Quality Engineer supports Design Controls and risk management activities and maintains the Design History File (DHF) to ensure compliance with applicable regulations. Partners with assay development, laboratory operations, regulatory affairs, and quality teams throughout the product lifecycle.

Job Responsibilities
- Create and update the Design and Development Plan (DDP) throughout the product lifecycle.
- Create and maintain the risk management file (risk management plan/report, hazard analysis, dFMEA, uFMEA).
- Provide mentorship, guidance, and training on design controls and risk management.
- Review and approve DHF deliverables (V&V plan/protocol/reports, requirements, specifications).
- Manage deviations and issues for verification and validation.
- Support design reviews and design transfer (process validations, pFMEA, DMR).
- Support design changes and post-market activities (change controls, CAPA).
- Perform risk assessments for regulatory submissions.
- Participate in process improvement initiatives (gap analysis and risk communication).
- May work on special projects related to design controls.

Required Qualifications
- Bachelor’s degree in engineering, scientific, or related field.
- 4+ years hands-on experience (or relevant comparable background).
- Ability to prepare and understand technical documentation (technical reports, V&V protocols/reports).
- Working knowledge of design controls, risk management, and product development.
- Experience with ISO 13485, CFR Part 820, ISO 14971.
- Working knowledge of U.S. and international medical device regulations and implementing quality systems.

Preferred Qualifications
- ISO 15189, CAP/CLIA, and GCP/GCLP.
- Adaptable to fast-paced, dynamic environments.
- Experience with eQMS.
- Experience supporting regulatory inspections.