Post Market Surveillance Engineer 2

Hologic • Marlborough, MA

2d

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 position applies knowledge of medical device quality systems and regulatory requirements, including FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, and risk management standards. It also supports post-market quality processes, product and process change requirements, documentation and testing updates, and related impact assessments.

The engineer works collaboratively across functions, communicates investigation results and recommendations to stakeholders and leadership, and conducts field investigations at customer sites with sales, service, and field-based teams. The role operates with intermediate autonomy and limited oversight on complex issues.

Requirements

• Bachelor’s degree in Engineering required.
• 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.
• Ability to assess product design and process changes, including documentation updates, testing, verification and validation, and impact assessments.
• Collaborative approach, accountability, attention to detail, sound judgment, and a compliance mindset.
• Effective communication with technical teams, leadership, and field-based partners.

Nice To Haves

• Mechanical, Electrical, Biomedical, or Biomechanical Engineering degree.
• Experience in an FDA-regulated industry.
• Experience in root cause analysis, product development, R&D, or medical device quality engineering.
• Experience supporting post-market medical devices, complaint investigations, CAPA evaluation, and regulated product changes.
• 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.
• Prioritize complaints based on risk, trends, data, and business impact, and drive timely resolution of quality issues.

Benefits

• Comprehensive training upon joining and continued development and training throughout the employee’s career.
• Bonus eligible.

What This Job Offers

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