Post Market Surveillance Engineer 2

Hologic • Marlborough, MA

3d • $78,000 - $122,100

About The Position

The Post Market Surveillance Engineer 2 provides quality engineering support for on-market medical devices. The role leads complaint investigations, risk assessments, root cause analysis, and cross-functional corrective actions to support product quality, regulatory compliance, and continuous improvement.

The engineer evaluates complaints and product quality trends, coordinates Health Risk Assessment activities, supports Quality Investigation Review boards, and works with cross-functional teams to determine corrective actions and CAPA decisions. The position also assesses product and project documentation for compliance, supports change control, communicates findings and recommendations to stakeholders and leadership, and conducts field investigations at customer sites with sales, service, and field-based teams.

The role requires a bachelor’s degree in engineering and 2–5 years of relevant engineering experience. The position operates with intermediate autonomy and calls for collaboration, accountability, sound risk-based judgment, attention to detail, and effective communication. Hologic provides comprehensive onboarding and continued training and development. The position is bonus eligible, with an annualized base salary range of $78,000–$122,100; final compensation depends on relevant experience, skills, knowledge, education, business needs, and market demand.

Requirements

• Bachelor’s degree in Engineering.
• 2–5 years of relevant engineering experience.
• Knowledge of medical device quality systems and regulatory requirements, including FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, and risk management standards.
• Knowledge of post-market quality processes, including complaint handling, investigations, risk assessment, Health Risk Assessments, CAPA evaluation, and change control.
• Knowledge of product design and process change requirements, including documentation updates, testing, verification and validation, and impact assessments.
• Ability to collaborate across functions and take ownership of investigations and quality issues.
• Ability to prioritize complaints based on risk, trends, data, and business impact.
• Strong accountability, compliance mindset, attention to detail, and effective communication with technical teams, leadership, and field-based partners.
• Ability to operate with intermediate autonomy, requiring limited oversight on complex issues.
• Ability to apply company policies and procedures consistently to resolve quality and product issues.

Nice To Haves

• Mechanical, Electrical, Biomedical, or Biomechanical Engineering degree specialization preferred.
• Experience in an FDA-regulated industry preferred.
• Experience in root cause analysis, product development, R&D, or medical device quality engineering is beneficial.
• Experience supporting post-market medical devices, complaint investigations, CAPA evaluation, and regulated product changes is preferred.
• Knowledge of test method validation, root cause failure analysis, statistical methods, design of experiments, reliability, electrical safety, sterilization, packaging, biocompatibility, and requirements analysis.

Responsibilities

• Conduct complaint evaluations, investigations, root cause analysis, risk assessments, and trend analysis for on-market medical devices.
• Lead cross-functional teams to determine corrective actions, implement improvements, and support CAPA decisions.
• Communicate investigation findings, root causes, recommended changes, and implementation scope to stakeholders and leadership.
• Assess product and project documentation for compliance and support change control activities.
• Present product quality metrics, investigation outcomes, and recommended resolutions to leadership.
• Coordinate Health Risk Assessment activities and support Quality Investigation Review boards.
• Perform field investigations at customer sites in partnership with sales, service, and field-based teams.
• Lead critical tasks and drive timely resolution of quality and product issues.

Benefits

• Comprehensive training when joining and continued development and training throughout the career.
• Bonus eligible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level