Hologic, Inc. · 2 weeks ago
Lead Design Assurance Engineer
Newark, DE
Full-time
Onsite
Senior Level, Lead/Staff
$119K/yr - $187K/yr
10+ years expHologic, Inc. is seeking a Lead Design Assurance Engineer to provide strategic and technical leadership in design controls, risk management, and quality systems for medical devices. The role involves partnering with various teams to ensure compliance and quality throughout the product lifecycle while driving continuous improvement and mentoring engineers.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Provide strategic and technical leadership in design controls, risk management, and quality systems across the product lifecycle
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
Drive continuous improvement, mentor engineers, and influence strategic initiatives to meet global standards for safety, effectiveness, and innovation
Qualification
Required
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)
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
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
Preferred
Preferred certifications: Certified Quality Engineer (ASQ CQE) and/or Six Sigma Black Belt
Benefits
Comprehensive training when you join as well as 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
2026-01-08
2026-01-07
Company data provided by crunchbase