Director, Design Assurance

Job description

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...