Lead Design Assurance Engineer

Hologic, Inc.; Marlborough (MA); On-site; USD 119,000 - 187,000; Full time

Job summary

Hologic, Inc. is seeking a Lead Design Assurance Engineer in the United States to drive design controls, risk management, and regulatory compliance from concept to product launch.

You will lead verification/validation, manage design inputs, and champion continuous improvement across cross‑functional teams. The role requires a strong background in medical device regulations, electro‑mechanical devices, and capital equipment, with 8+ years of industry experience or 5+ years with a Master’s degree.

Qualifications

• Deep knowledge of medical device regulations and standards (ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP)
• Experience with electro‑mechanical devices and capital equipment
• Strong design inputs/requirements analysis, verification/validation, and design transfer experience
• Advanced risk management, hazard analysis and FMEA (Design, Usability, and Process)
• Proficiency in test method validation, statistics, and root-cause investigations

Responsibilities

• Define clear design requirements from concept to launch.
• Oversee verification/validation and design transfer activities.
• Champion continuous improvement initiatives to enhance product quality and compliance.
• Collaborate with R&D, Regulatory Affairs, and Manufacturing to ensure alignment on design and regulatory goals.

Skills

Leadership

Regulatory knowledge

Risk management

Verification/Validation

Statistical analysis

Project management

Documentation

Cross-functional collaboration

Continuous improvement

Education

Bachelor of Science in engineering

Master’s degree preferred

Job description

Lead Design Assurance Engineer

Newark, DE, United States

Marlborough, MA, United States

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!

Knowledge:

• 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.

Skills:

• 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.

Behaviors:

• 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.

Experience:

• Bachelor of Science degree in a related engineering discipline required; Master’s degree preferred.

• 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.

• Hands‑on experience with electro‑mechanical devices and capital equipment is preferred.

• 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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $119,300 - $186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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