Lead Design Assurance Engineer

Hologic•Newark, DE

1d•$119,300 - $186,600

About The Position

Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development, ensuring that design controls, risk management, and global regulatory compliance are maintained from concept to product launch. In this role, you’ll work cross-functionally to define clear design requirements, oversee verification and validation processes, and champion continuous improvement initiatives. If you’re a strategic thinker with hands-on expertise in design assurance and a commitment to delivering safe, reliable, and durable medical devices, we want to hear from you!

Requirements

In-depth understanding of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP.
Familiarity with reliability modeling and testing for electro-mechanical devices and capital equipment.
Expertise in design inputs/requirements analysis, design verification/validation, and design transfer processes.
Advanced knowledge of risk management principles, including hazard analysis and FMEA (Design, Usability, and Process).
Thorough understanding of test method validation, statistical methods, and failure investigations/root cause analysis.
Proven ability to lead design assurance efforts across the product lifecycle, from concept to launch and post-market activities.
Strong analytical and problem-solving skills to identify gaps, assess risk, and implement corrective actions.
Effective project management skills, including prioritization, planning, and timely execution of critical tasks.
Exceptional communication and collaboration skills to work with cross-functional teams and ensure alignment on design and compliance goals.
Ability to critically assess and advocate for compliance in written product and project documentation.
Leadership and mentoring skills to guide junior engineers and foster a culture of quality and innovation.
Familiarity with continuous improvement practices and strategies to optimize processes and enhance product quality.
Ownership-driven, taking responsibility for deliverables and ensuring adherence to regulatory and quality standards.
Proactive and detail-oriented, with a focus on driving efficiency and maintaining compliance.
Collaborative and team-oriented, building strong relationships across R&D, Regulatory Affairs, Manufacturing, and other key stakeholders.
Customer-focused, committed to developing innovative solutions that enhance product safety, reliability, and usability.
Strategic thinker, leveraging data and industry insights to inform decisions and improve processes.
Committed to continuous improvement, driving initiatives to optimize product development and design assurance performance.
Bachelor of Science degree in a related engineering discipline required.
8+ years of medical device industry experience with a Bachelor’s degree in a related engineering discipline, or 5+ years of experience with a Master’s degree.
Proven track record in design assurance activities, including verification/validation, risk management, and regulatory compliance.
Demonstrated expertise in test method validation, statistical analysis, and root cause failure investigations.

Nice To Haves

Master’s degree preferred.
Hands-on experience with electro-mechanical devices and capital equipment is preferred.

Responsibilities

Play a pivotal role in new product development, ensuring that design controls, risk management, and global regulatory compliance are maintained from concept to product launch.
Work cross-functionally to define clear design requirements.
Oversee verification and validation processes.
Champion continuous improvement initiatives.
Lead design assurance efforts across the product lifecycle, from concept to launch and post-market activities.
Identify gaps, assess risk, and implement corrective actions.
Prioritize, plan, and execute critical tasks in a timely manner.
Work with cross-functional teams and ensure alignment on design and compliance goals.
Critically assess and advocate for compliance in written product and project documentation.
Guide junior engineers and foster a culture of quality and innovation.
Optimize processes and enhance product quality.
Take responsibility for deliverables and ensure adherence to regulatory and quality standards.
Drive efficiency and maintain compliance.
Build strong relationships across R&D, Regulatory Affairs, Manufacturing, and other key stakeholders.
Develop innovative solutions that enhance product safety, reliability, and usability.
Leverage data and industry insights to inform decisions and improve processes.
Drive initiatives to optimize product development and design assurance performance.