Senior SaMD Design Quality Engineer

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

Job summary

Hologic, Inc. in Marlborough, MA, seeks a Senior Software Design Quality Engineer to own software design quality across the NPD lifecycle. You will drive risk management integration per ISO 14971, ensure IEC 62304 alignment, and oversee design inputs/outputs for regulated IVD software.

The role emphasizes post-market signal use, robust V&V strategies, and strong collaboration with R&D, Regulatory, and Service teams to meet SaMD expectations and industry standards.

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.
• Experience in software NPD / design assurance activities in regulated medical devices, including design controls and risk management.
• Deep knowledge of ISO 13485, FDA QMSR (21 CFR 820), ISO 14971, and IEC 62304.

Responsibilities

• Acts 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, testable, and aligned to intended use.
• Approves software design quality deliverables, including risk analyses, V&V strategy, and design reviews.
• Leads analysis of software-related failure modes and drives design improvements.

Skills

Software design controls

Risk management

SaMD experience

Regulatory compliance

Cross-functional leadership

Education

Bachelor’s degree in computer science or related

Advanced degree preferred

Tools

ISO 13485

FDA QMSR (21 CFR 820)

IEC 62304

Job description

Hologic, Inc. in Marlborough, MA, seeks a Senior Software Design Quality Engineer to own software design quality across the NPD lifecycle. You will drive risk management integration per ISO 14971, ensure IEC 62304 alignment, and oversee design inputs/outputs for regulated IVD software.

The role emphasizes post-market signal use, robust V&V strategies, and strong collaboration with R&D, Regulatory, and Service teams to meet SaMD expectations and industry standards.