US_East | QA / Quality Engineer_L4
Expedite Technology Solutions LLC
Verification Lead
We are seeking a Verification Lead to own the verification strategy for our medical device products and ensure that our software and systems meet their specified requirements and in compliance with applicable regulatory standards (FDA and notified body audits). This is a hands-on technical leadership role that bridges engineering, quality, and regulatory affairs. You will design verification protocols, drive risk-based test coverage, and mentor a team of verification engineers.
Key Responsibilities
- Verification Strategy & Planning
- Risk-Based Verification
- Test Protocol Design & Execution
- Reviews & Technical Governance
- Documentation & Compliance
- Leadership
Required Qualifications
- Bachelor's degree in engineering, computer science, or a related technical field (or equivalent experience).
- 8+ years in verification, V&V, in medical devices.
- Demonstrated working knowledge of IEC 62304 (software lifecycle and safety classification) and ISO 14971 (risk management).
- Proficient in connected devices, embedded systems, or SaMD (Software as a Medical Device).
- Experience authoring verification plans and designing test protocols from requirements.
- Strong grasp of requirements traceability and design control processes.
- Experience leading technical reviews and producing audit-ready documentation.
- Excellent written communication; able to write protocols and reports that withstand regulatory review.
- Experience supporting regulatory submissions and notified body audits.
Vacancy posted 4 days ago
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