Senior Software Design Quality Engineer

Essential Duties and Responsibilities

• The incumbent may be required to perform additional duties related to the functions listed below:

Software Design Quality Ownership

Risk Management Integration

Verification and Validation Strategy

Software and System Behavior

Post-Market Signal Integration

Cross-Functional Leadership

Requirements / Qualifications

• Qualifications will be assessed holistically, and equivalent education, experience, and demonstrated skills may fulfill these 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 SaMD and QI/ML-enabled medical devices preferred; familiarly with FDA guidance on AI/ML and the EU Act is a plus.
• Strong technical leadership, cross-functional influence, and written communication skills.
• Experience with software system architecture, interfaces, and failure modes in complex electromechanical systems.
• Preferred certifications: ASQ CQE or CSQE, or a comparable quality or reliability certification.
• Why join Hologic?
• We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
• The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
• Agency and Third-Party Recruiter Notice
• Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
• #LI-AV1
• Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.