Job DescriptionAre 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.
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 NoticeAgencies 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.
#LI-NK1
