Quick Overview
Job Description
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.
Skills
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