Senior Software Design Quality Engineer

Hologic•Marlborough, MA

10h•$97,600 - $152,700

About The Position

The Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics (IVD) medical devices across the development lifecycle. This includes software-enabled diagnostic systems incorporating image analysis and AI/ML-based algorithms to support detection and classification of cellular abnormalities. Embedded on New Product Development (NPD) core teams, this role owns software design controls, drives integration of ISO 14971 risk management into the software development lifecycle (SDLC), and ensures alignment to IEC 62304 and applicable Software as a Medical Device (SaMD) expectations. Post-market signals are leveraged as structured inputs to design improvements. Ensures traceability and alignment across design inputs, verification, and validation to meet regulatory expectations under all applicable design and development regulations and standards.

Requirements

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 comparable 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 software system architecture, interfaces, and failure modes in complex electromechanical systems.

Nice To Haves

Experience with SaMD and QI/ML-enabled medical devices preferred; familiarly with FDA guidance on AI/ML and the EU Act is a plus.
Preferred certifications: ASQ CQE or CSQE, or a comparable quality or reliability certification.

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, testable, and aligned to intended use.
Ensures design outputs are appropriately translated into production specifications.
Approves software design quality deliverables, including design inputs, risk analyses, V&V strategy, and design reviews.
Owns software-related risk management activities per ISO 14971.
Ensures traceable linkage between hazards, design requirements, and verification evidence.
Maintains risk files with production and post-production feedback per ISO 14971 Section 10.
Approves risk-based V&V approaches for software systems.
Ensures validation reflects real-world use conditions and user needs.
Confirms V&V coverage is traceable to requirements and identified hazards.
Determines adequacy of verification and validation evidence relative to intended use and risk.
Leads analysis of software-related failure modes, with focus on real-world use conditions and system interactions.
Drives design improvements to strengthen system robustness, error handling, and user-visible behavior.
Ensures software and system behavior are sufficiently defined and diagnosable to support effective investigation of field issues.
Reviews software-related complaint trends and field signals as inputs to design.
Translates signals into design improvements, risk file updates, or verification gap closure.
Engages in complaint investigations where software or system behavior indicates potential design or risk control gaps.
Drives alignment across R&D, Systems, Regulatory, and Service.
Influences product decisions to improve quality, reliability, and compliance.
Mentors junior engineers on software design quality practices.
Serves as the quality authority in design reviews, providing independent oversight per ISO 13485 design control expectations.