Director, Design Assurance
Hologic, Inc., Newark, DE, 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)
Benefits
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.
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.
#J-18808-Ljbffr
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)
Benefits
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.
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.
#J-18808-Ljbffr