Director, Design Assurance

Hologic•Newark, NJ

13h

About The Position

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.

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
Knowledge of Medical device quality systems and regulatory frameworks
Knowledge of Design controls and product development lifecycle management
Knowledge of Risk management principles and ISO 14971
Knowledge of Design History File (DHF) structure and documentation expectations
Knowledge of Verification and validation strategies
Knowledge of Requirements management and traceability
Knowledge of Design transfer and change control processes

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.
Apply design controls in both development and sustaining environments.
Support new product development and product launches.
Manage teams and develop technical talent, including managing managers.
Drive effective design reviews, verification, validation, and product transfer readiness.
Influence stakeholders and align teams around product quality outcomes.
Solve problems and resolve issues across development and sustaining engineering.