Director, Design Assurance

Hologic is seeking a Director of Design Assurance to lead quality strategy for a highvisibility 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.

Youll partner closely with R&D Program Management Manufacturing Regulatory and Medical Safety teams to embed practical riskbased design controls throughout the product lifecyclefrom early concept through commercialization and postmarket 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.

• 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)

• Strategic leadership of quality and design assurance functions
• Crossfunctional collaboration with engineering regulatory manufacturing and clinical teams
• Riskbased decision making within complex product development programs
• Building and leading highperforming 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

• Collaborative leadership that partners closely with R&D and product teams
• Practical solutionsfocused 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

• Bachelors 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 handson experience applying design controls in both development and sustaining environments
• Experience working in a regulated medical device environment
• Background supporting electromechanical and/or softwareenabled 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 cant wait to hear from you!

The annualized base salary range for this role is $167400 - $297600 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 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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