Hologic, Inc. · 2 days ago
Lead Design Assurance Engineer
Newark, DE
Full-time
Onsite
Senior Level, Lead/Staff
$119K/yr - $187K/yr
8+ years expHologic, Inc. is seeking a Lead Design Assurance Engineer to play a pivotal role in new product development. This role involves ensuring design controls, risk management, and global regulatory compliance are maintained from concept to product launch, while working cross-functionally to define design requirements and oversee verification and validation processes.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Drive innovation while ensuring compliance and quality in medical device development
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, and 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
Plan and execute critical tasks in a timely manner
Communicate and collaborate with cross-functional teams to 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 through continuous improvement practices
Qualification
Required
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
Preferred
Master's degree preferred
Hands-on experience with electro-mechanical devices and capital equipment is preferred
Benefits
Comprehensive training
Continued development and training throughout your career
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-01
Dallas Morning News
2025-12-26
Company data provided by crunchbase