Job Description

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.

Knowledge

• 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.
• Preferred: Knowledge of design controls, post-market surveillance, and root cause failure analysis.
• Familiarity with complex medical devices (software, electromechanical systems) at the system level.

Skills

• 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.

Behaviors

• 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.

Experience

• 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.
• Beneficial: Experience supporting complex medical devices (software or electromechanical) at the system level.

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 Notice

Agencies 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.

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