Lead Design Assurance Engineer

Hologic, Inc.; Newark (DE); On-site; USD 119,300 - 186,600; Full time

Job summary

Hologic, Inc. in Newark, Delaware is looking for a Lead Design Assurance Engineer to ensure compliance and quality in medical device development. This role involves defining design requirements, overseeing verification processes, and driving continuous improvement initiatives.

The ideal candidate will have over 8 years of experience in the medical device industry, with a strong focus on design assurance and regulatory compliance. Relevant education and hands-on experience with electro-mechanical devices are also required.

Qualifications

• 8+ years of medical device experience with a Bachelor's, or 5+ years with a Master's degree.
• Hands-on experience with electro-mechanical devices preferred.
• Proven track record in design assurance activities and risk management.

Responsibilities

• Ensure design controls, risk management, and regulatory compliance for new products.
• Work cross-functionally to define design requirements and oversee validation processes.
• Champion continuous improvement initiatives across product lifecycle.

Skills

Leadership and mentoring skills

Strong analytical and problem-solving skills

Effective project management skills

Exceptional communication and collaboration skills

Proven ability to lead design assurance efforts

Education

Bachelor of Science in a related engineering discipline

Master’s degree preferred

Tools

Statistical analysis tools

Reliability modeling tools

Job description

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.

Salary

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, skill set, knowledge, education, business needs and market demand.

Equal Opportunity Employer

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