Job Description
Lead Software Design Assurance Engineer
Marlborough, MA, United States
Newark, DE, United States
Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software? Hologic is seeking a **Lead Software Design Assurance Engineer** to play a critical role in driving compliance, innovation, and excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD). In this role, you’ll lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory standards. If you’re an experienced professional with a strong background in software engineering, regulatory compliance, and mentoring, this is your opportunity to make a meaningful impact on healthcare innovation.
**Knowledge:**
+ Deep understanding of global medical device software regulations, including FDA 21 CFR Par...
Marlborough, MA, United States
Newark, DE, United States
Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software? Hologic is seeking a **Lead Software Design Assurance Engineer** to play a critical role in driving compliance, innovation, and excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD). In this role, you’ll lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory standards. If you’re an experienced professional with a strong background in software engineering, regulatory compliance, and mentoring, this is your opportunity to make a meaningful impact on healthcare innovation.
**Knowledge:**
+ Deep understanding of global medical device software regulations, including FDA 21 CFR Par...
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