Lead Risk Management Quality Engineer

Hologic•Marlborough, MA

4h•$119,300 - $186,600

About The Position

Hologic’s mission is to enable healthier lives everywhere, every day—and robust risk management is critical to that mission. We’re looking for a Lead Risk Management Quality Engineer to ensure the safety and compliance of both on‑market and pre‑market medical devices by serving as the organization’s key risk expert. In this high‑impact role, you’ll lead risk management activities across the product lifecycle, drive improvements to risk processes and procedures, and mentor teams in best‑in‑class risk practices. If you enjoy influencing systems, shaping strategy, and translating complex risks into clear, data‑driven decisions, this role is for you.

Requirements

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.
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.

Nice To Haves

Knowledge of design controls, post‑market surveillance, and root cause failure analysis.
Familiarity with complex medical devices (software, electromechanical systems) at the system level.
Experience supporting complex medical devices (software or electromechanical) at the system level.