Description
Hologic is hiring a Senior Software Design Quality Engineer to serve as the design quality authority for software-enabled in-vitro diagnostics medical devices. The role owns software design controls, integrates ISO 14971 risk management into the software development lifecycle, approves design and verification/validation deliverables, ensures traceability across requirements and evidence, analyzes software failure modes, and translates post-market signals into design improvements. The position requires a bachelor’s degree in a relevant technical discipline, at least 8 years of quality, software, or systems engineering experience in a medical device or comparable regulated industry, and expertise with ISO 13485, FDA QMSR, ISO 14971, and IEC 62304. The annualized base salary range is $97,600-$152,700, with bonus eligibility.
