Director Global Design Controls & Risk Management

Hologic•Newark, DE

About The Position

Hologic is committed to enabling healthier lives everywhere, every day—and robust Design Controls and Risk Management are fundamental to that mission. As Director, Global Design Controls & Risk Management, you will be the Global Process Owner, providing end-to-end leadership, ownership, and governance of the enterprise Design Controls and Risk Management framework across all divisions, regions, and product lines. In this highly strategic role, you will assess and harmonize existing processes, define and deploy a unified global framework that meets regulatory requirements and business needs, and drive its adoption across the organization. You’ll ensure Design Controls and Risk Management are seamlessly embedded into product development and lifecycle management, enabling consistent compliance, risk reduction, and high-quality product outcomes worldwide. As the central authority and primary point of contact for Design Controls and Risk Management processes, tools, and training, you’ll provide ongoing global support and lead continuous improvement well beyond initial implementation.

Requirements

In-depth knowledge of Design Controls requirements and frameworks, including FDA 21 CFR 820.30, ISO 13485, and applicable elements of EU MDR/IVDR and other regional regulatory expectations.
Strong understanding of risk management principles and standards, including ISO 14971, and the integration of risk management activities throughout the product lifecycle (concept, design, development, transfer, commercialization, and post-market).
Comprehensive understanding of product development lifecycle models (e.g., waterfall, V-model, hybrid, agile) and how Design Controls and Risk Management are applied within different development approaches.
Knowledge of requirements management, design verification and validation methodologies, usability/human factors engineering, and design transfer practices.
Familiarity with various risk management tools and methodologies (e.g., FMEA, FTA, hazard analysis, risk matrices, usability risk assessment, benefit-risk analysis) and their practical application in medical device or similarly regulated environments.
Knowledge of electronic tools and systems commonly used in Design Controls and Risk Management (e.g., eQMS, PLM, ALM, requirements and risk management software) and their role in enabling traceability and data integrity.
Familiarity with global quality governance and operating models, including central vs. local responsibilities, process ownership, and harmonization across multiple sites and business units.
Proven ability to design, harmonize, and implement global processes for Design Controls and/or Risk Management across multiple divisions, sites, and regions.
Strong capability to interpret and apply regulatory and standard requirements, and translate them into clear, practical, and scalable procedures, templates, and tools.
Demonstrated experience in leading cross-functional, cross-site process transformation and harmonization initiatives, including: Process mapping Gap assessment Roadmapping and change management.
Ability to lead global deployment efforts, including stakeholder engagement, communications, training, and adoption monitoring—with a track record of driving sustainable behavioral and process change.
Strong facilitation and influencing skills, able to manage diverse stakeholder perspectives, negotiate trade-offs, and secure alignment on standard processes without direct line authority.
Experience in developing and delivering targeted training and coaching on Design Controls and Risk Management concepts, requirements, and tools to technical and non-technical audiences globally.
Skilled at defining and monitoring KPIs and process performance metrics, and presenting trends and insights to senior leadership for decision-making.
Comfortable partnering with Regulatory and Quality to prepare for and support audits/inspections, and to respond effectively to Design Controls and Risk Management-related findings.
Enterprise-minded leader who thinks end-to-end, balancing regulatory rigor, product innovation, and operational practicality.
Highly collaborative and influential, building strong partnerships across R&D, Quality, Regulatory, Clinical, Operations, and regional business teams.
Change leader who can articulate a compelling vision for harmonized Design Controls and Risk Management and drive adoption across cultures and regions.
Data-driven and strategic, using performance metrics, lessons learned, and audit feedback to continuously improve processes and tools.
Clear, confident communicator, able to engage senior leadership and diverse teams with clarity and credibility.
Bachelor’s degree in Engineering, Science, Quality, or a related technical field required.
Minimum 8–10+ years of experience in medical devices and/or diagnostics, with significant focus on Design Controls, Risk Management, New product Development and establishing DHF strategy
Demonstrated experience owning or leading Design Controls and/or Risk Management processes at an enterprise, multi-site, or divisional level.
Proven track record of leading global or multi-site process harmonization, standardization, or transformation initiatives.
Experience interfacing with regulatory bodies and notified bodies on Design Controls and Risk Management topics, including participation in audits and inspections.
Prior experience working in a global, matrixed organization and collaborating effectively across R&D, Quality, Regulatory, Clinical, Operations, and regional business teams strongly preferred.
Minimum 8–10+ years of experience in medical devices and/or diagnostics, with significant focus on Design Controls, Risk Management, New product Development and establishing DHF strategy.
Demonstrated experience owning or leading Design Controls and/or Risk Management processes at an enterprise, multi-site, or divisional level.
Proven track record of leading global or multi-site process harmonization, standardization, or transformation initiatives.
Experience interfacing with regulatory bodies and notified bodies on Design Controls and Risk Management topics, including participation in audits and inspections.
Prior experience working in a global, matrixed organization and collaborating effectively across R&D, Quality, Regulatory, Clinical, Operations, and regional business teams strongly preferred.

Nice To Haves

Advanced degree (e.g., MS, MEng, MBA, or related) preferred.
Prior experience working in a global, matrixed organization and collaborating effectively across R&D, Quality, Regulatory, Clinical, Operations, and regional business teams strongly preferred.
Prior experience working in a global, matrixed organization and collaborating effectively across R&D, Quality, Regulatory, Clinical, Operations, and regional business teams strongly preferred.