Hologic, Inc. · 17 hours ago
Lead Risk Management Quality Engineer
Marlborough, MA
Full-time
Onsite
Senior Level, Lead/Staff
$119K/yr - $187K/yr
7+ years expHologic, Inc. is committed to enabling healthier lives through robust risk management. They are seeking a Lead Risk Management Quality Engineer to ensure the safety and compliance of medical devices by leading risk management activities and mentoring teams in best practices. This role involves driving improvements to risk processes and translating complex risks into data-driven decisions.
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Responsibilities
Lead risk management activities across the product lifecycle
Drive improvements to risk processes and procedures
Mentor teams in best‑in‑class risk practices
Own and author risk analyses and other risk management documentation
Perform gap assessments, planning, organizing, executing, and reporting risk management activities and remediation projects
Develop and improve risk management processes, procedures, tools, and practices for continuous improvement
Develop and implement key performance indicators (KPIs) and metrics to monitor risk management process performance
Support Health Risk Assessments and Health Hazard Evaluations as part of post‑market surveillance
Communicate risk recommendations to stakeholders
Lead cross‑functional project teams, ensuring timely and appropriate completion of critical tasks
Teach, coach, and train others in risk management practices
Qualification
Required
Deep expertise in ISO 14971:2019 (Risk Management for Medical Devices) and EU MDR (2017/745) risk requirements
Strong understanding of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485
In‑depth knowledge of industry best practices and emerging trends in risk management processes, tools, and technologies
Working knowledge of verification and validation requirements in the medical device industry
Understanding of requirements analysis, including development of testable and measurable specifications
Familiarity with complex medical devices (software, electromechanical systems) at the system level
Proven ability to own and author risk analyses and other risk management documentation (hazard identification, risk evaluation, risk controls, residual risk assessments)
Skilled in performing gap assessments, planning, organizing, executing, and reporting risk management activities and remediation projects
Experience developing and improving risk management processes, procedures, tools, and practices for continuous improvement
Ability to develop and implement key performance indicators (KPIs) and metrics to monitor risk management process performance
Strong statistical acumen beyond basic SPC, including use of statistical techniques to support risk assessments (e.g., probability of hazardous situations)
Capable of effectively supporting Health Risk Assessments and Health Hazard Evaluations as part of post‑market surveillance
Strong communication skills to act as the principal advocate for risk management, clearly assessing documentation and conveying risk recommendations to stakeholders
Proven ability to lead cross‑functional project teams, taking ownership of critical tasks to ensure timely and appropriate completion
Demonstrated ability to teach, coach, and train others in risk management practices, from individual mentoring to group training sessions
Operates with a high degree of independence, demonstrating sound judgment in managing priorities and resolving conflicts
Acts as a risk champion, consistently advocating for patient safety and robust, risk‑based decision‑making
Collaborative and influential, able to work effectively with R&D, Quality, Regulatory, Operations, and Post‑Market teams
Detail‑oriented and systematic, ensuring risk files are complete, compliant, and clearly traceable
Proactive and improvement‑focused, continually seeking opportunities to strengthen risk processes and build organizational risk competency
Clear, concise communicator who can simplify complex risk concepts for a variety of audiences and skill levels
Bachelor's Degree in Engineering required (Mechanical, Electrical, Biomechanical, or Biomedical preferred)
7+ years of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, Electrical Engineering, or related field
Experience in an FDA‑regulated industry is required, with direct ownership of risk analysis and risk management documentation
Preferred
Knowledge of design controls, post‑market surveillance, and root cause failure analysis
Beneficial: Experience supporting complex medical devices (software or electromechanical) at the system level
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
2026-02-07
Medical Product Outsourcing
2026-02-06
2026-02-05
Company data provided by crunchbase