Director, Design Assurance

Hologic•Newark, DE

About The Position

Hologic is seeking a Director of Design Assurance to lead quality strategy for a high-visibility portfolio within its Breast & Skeletal Health division. This role is 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. The Director will 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.

Requirements

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
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
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
Problem solving and issue resolution across development and sustaining engineering
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

Nice To Haves

Standards relevant to medical devices such as IEC 60601, IEC 62304, and IEC 62366
Quality systems and PLM platforms such as Agile or Oracle
Background supporting electromechanical and/or software-enabled medical devices

Responsibilities

Lead quality strategy for a high-visibility portfolio within the Breast & Skeletal Health division.
Partner closely with R&D, Program Management, Manufacturing, Regulatory, and Medical Safety teams.
Embed practical, risk-based design controls throughout the product lifecycle.
Enable strong product decisions.
Strengthen development execution.
Build organizational capability as the portfolio grows.
Drive effective design reviews, verification, validation, and product transfer readiness.
Influence stakeholders and align teams around product quality outcomes.
Guide teams through complex product decisions in regulated environments.