Senior SaMD Design Quality Lead

Hologic, Inc.; Marlborough (MA); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic, Inc. is seeking a Senior Software Design Quality Engineer to lead software quality across the development lifecycle for AI/ML-enabled IVD devices.

You will own design quality controls, drive risk management integration per ISO 14971, and ensure alignment to IEC 62304 and SaMD expectations within New Product Development teams. The role requires deep regulatory knowledge, cross-functional leadership, and the ability to translate field signals into design improvements while maintaining

Qualifications

• Bachelor’s degree in computer science, software engineering, or related technical discipline; advanced degree preferred.
• 8+ years of experience in quality, software, or systems engineering within the medical device or regulated industry.
• Demonstrated experience in software NPD / design assurance activities in regulated medical devices, including design controls and risk management.
• Deep working knowledge of ISO 13485, FDA QMSR (21 CFR 820), ISO 14971, and IEC 62304.
• Proven experience translating field issues into design changes and closed-loop risk updates.
• Experience with SaMD and ML-enabled medical devices; familiarity with FDA AI/ML guidance and EU Act is a plus.
• Strong technical leadership, cross-functional influence, and written communication skills.

Responsibilities

• Serves as Design Quality representative on software NPD core teams.
• Owns design quality strategy for new and modified software-enabled products.
• Ensures design inputs are complete and aligned to use; translate outputs to production specs.
• Approves software design quality deliverables including inputs, risk analyses, V&V strategy, design reviews.
• Leads software-related risk management activities per ISO 14971.
• Ensures traceable linkage between hazards, requirements, and verification evidence.

Skills

Leadership

Cross-functional influence

Written communication

Education

Bachelor’s degree in computer science or software engineering

Advanced degree preferred

Tools

ISO 13485

FDA QMSR (21 CFR 820)

ISO 14971

IEC 62304

Job description

Hologic, Inc. is seeking a Senior Software Design Quality Engineer to lead software quality across the development lifecycle for AI/ML-enabled IVD devices.

You will own design quality controls, drive risk management integration per ISO 14971, and ensure alignment to IEC 62304 and SaMD expectations within New Product Development teams. The role requires deep regulatory knowledge, cross-functional leadership, and the ability to translate field signals into design improvements while maintaining