Lead Design Assurance Engineer
Hologic
Newark, DE, United States, DE
Compensation: $119300 to $186600 per year
Are you ready to take the lead in ensuring the safety, reliability, and compliance of life-changing medical devices? At Hologic, we are seeking a Lead Design Assurance Engineer to provide strategic and technical leadership in design controls, risk management, and quality systems across the product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs, and Manufacturing Engineering teams to embed quality and compliance principles into every stage of development and post-market activities. With your advanced technical expertise and leadership skills, you will drive continuous improvement, mentor engineers, and influence strategic initiatives to ensure Hologic’s products meet the highest global standards for safety, effectiveness, and innovation.
Knowledge:
- Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019 (Risk Management), and EU MDR (Regulation 2017/745).
- Advanced understanding of medical device standards, including usability, reliability, electrical safety, and software regulations.
- Thorough knowledge of design control processes, verification and validation planning, and requirements traceability.
- Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices.
- Proficiency in statistical methods, test method validation (TMV), root cause analysis (RCA), and design of experiments (DOE).
Skills:
- Proven ability to lead cross-functional teams in implementing design controls and risk management across the product lifecycle.
- Expertise in developing testable, measurable specifications aligned with risk-based methodologies.
- Strong technical writing and communication skills for preparing and presenting complex regulatory and quality concepts to diverse audiences.
- Ability to assess complex design documentation and advocate for compliance effectively.
- Proficient in statistical tools like Minitab or JMP and requirements/risk management systems such as Agile, Windchill, or ETQ.
- Exceptional leadership and mentorship abilities to develop and guide engineers, fostering technical depth and a culture of quality excellence.
- Skilled in managing multiple priorities with independence, accountability, and sound professional judgment.
- Preferred certifications: Certified Quality Engineer (ASQ CQE) and/or Six Sigma Black Belt.
Behaviors:
- Ownership-driven, taking responsibility for ensuring safety, compliance, and effectiveness in all product development and sustaining activities.
- Strategic thinker with a focus on innovation and continuous improvement in design assurance practices.
- Collaborative and relationship-oriented, building strong partnerships across R&D, Regulatory, Operations, and Quality teams.
- Proactive and detail-oriented, ensuring timely execution of critical tasks and deliverables.
- Committed to fostering a culture of quality and regulatory excellence, both within teams and across the organization.
- Flexible and adaptable, thriving in a fast-paced, regulated environment while managing competing priorities.
Experience:
- Bachelor’s degree in Engineering, Biomedical Engineering, or related technical field required; Master’s or Ph.D. preferred.
- 10+ years of experience in Design Assurance, Quality Engineering, or related technical roles within the medical device industry with a Bachelor’s degree in Engineering or Life Sciences.
- 8+ years with a Master’s degree or 5+ years with a Ph.D. in Engineering, Biomedical Science, or a related discipline.
- Hands-on experience with design controls, risk management, verification/validation, and sustaining engineering for medical devices.
- Proven track record of leading audits, regulatory inspections, and remediation initiatives.
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.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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