Director, Design Assurance

Director, Design Assurance Newark, DE, United States Louisville, CO, United States Marlborough, MA, United States Hologic is seeking a

• Director of Design Assurance
• to lead quality strategy for a high‑visibility portfolio within our Breast & Skeletal Health division.

This role sits at the intersection of quality, engineering, and product development, ensuring that new and existing medical devices are designed with safety, reliability, and performance at their core. You'll partner closely with R D, Program Management, Manufacturing, Regulatory, and Medical Safety teams to embed practical, risk‑based design controls throughout the product lifecycle—from early concept through commercialization and post‑market support. This is a highly collaborative leadership role focused on enabling strong product decisions, strengthening development execution, and building organizational capability as the portfolio grows. Knowledge + Medical device quality systems and regulatory frameworks + Design controls and product development lifecycle management + Risk management principles and

ISO 14971

+ Design History File (DHF) structure and documentation expectations + Verification and validation strategies + Requirements management and traceability + Design transfer and change control processes + Standards relevant to medical devices such as

IEC 60601, IEC

62304, and

IEC 62366

(preferred) + Quality systems and PLM platforms such as Agile or Oracle (preferred) Skills + Strategic leadership of quality and design assurance functions + Cross‑functional collaboration with engineering, regulatory, manufacturing, and clinical teams + Risk‑based decision making within complex product development programs + Building and leading high‑performing technical teams + Translating user and clinical needs into product quality and design strategies + Driving effective design reviews, verification, validation, and product transfer readiness + Influencing stakeholders and aligning teams around product quality outcomes + Problem solving and issue resolution across development and sustaining engineering Behaviors + Collaborative leadership that partners closely with R D and product teams + Practical, solutions‑focused approach to quality and regulatory requirements + Strategic thinker who balances compliance, risk, and business priorities + Strong communicator who can influence across functions and levels + Commitment to patient safety and product excellence + Proactive mindset toward continuous improvement and organizational development + Ability to guide teams through complex product decisions in regulated environments Experience + Bachelor's degree in Engineering (Mechanical, Electrical, or related technical discipline) + 12+ years of experience in medical device quality engineering, design assurance, R D, or related engineering functions + Proven experience supporting new product development and product launches + Leadership experience managing teams and developing technical talent (including managing managers) + Significant hands‑on experience applying design controls in both development and sustaining environments + Experience working in a regulated medical device environment + Background supporting electromechanical and/or software‑enabled medical devices (preferred)

• So why join Hologic?
• We are committed to making Hologic the company where top talent comes to grow.

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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you! The annualized base salary range for this role is $167,400 - $297,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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.
• Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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