Surveillance Analyst

Summary

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

Knowledge

• Medical device quality systems and regulatory requirements, including FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, and risk management standards.
• Post-market quality processes, including complaint handling, investigations, risk assessment, Health Risk Assessments, CAPA evaluation, and change control.
• Product design and process change requirements, including documentation updates, testing, verification and validation, and impact assessments.
• Preferred knowledge of test method validation, root cause failure analysis, statistical methods, design of experiments, reliability, electrical safety, sterilization, packaging, biocompatibility, and requirements analysis.

Skills

• Conducts complaint evaluations, investigations, root cause analysis, risk assessments, and trend analysis for on-market medical devices.
• Leads cross-functional teams to determine corrective actions, implement improvements, and support CAPA decisions.
• Communicates investigation findings, root cause, recommended changes, and implementation scope clearly to stakeholders and leadership.
• Assesses product and project documentation for compliance and supports change control activities.
• Presents product quality metrics, investigation outcomes, and recommended resolutions to leadership.
• Coordinates Health Risk Assessment activities and supports Quality Investigation Review boards.
• Performs field investigations at customer sites in partnership with sales, service, and field-based teams.

Behavior

• Works collaboratively across functions and takes ownership of investigations and quality issues.
• Demonstrates sound judgment in prioritizing complaints based on risk, trends, data, and business impact.
• Operates with intermediate autonomy, requiring limited oversight on complex issues.
• Shows strong accountability, compliance mindset, and attention to detail.
• Communicates effectively with technical teams, leadership, and field-based partners.
• Applies company policies and procedures consistently to resolve quality and product issues.
• Takes initiative to lead critical tasks and drive timely resolution.

Experience

• Bachelor's degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
• 2–5 years of relevant engineering experience.
• 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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

#LI-NK1

Job Description

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

Knowledge

• Medical device quality systems and regulatory requirements, including FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, and risk management standards.
• Post-market quality processes, including complaint handling, investigations, risk assessment, Health Risk Assessments, CAPA evaluation, and change control.
• Product design and process change requirements, including documentation updates, testing, verification and validation, and impact assessments.
• Preferred knowledge of test method validation, root cause failure analysis, statistical methods, design of experiments, reliability, electrical safety, sterilization, packaging, biocompatibility, and requirements analysis.

Skills

• Conducts complaint evaluations, investigations, root cause analysis, risk assessments, and trend analysis for on-market medical devices.
• Leads cross-functional teams to determine corrective actions, implement improvements, and support CAPA decisions.
• Communicates investigation findings, root cause, recommended changes, and implementation scope clearly to stakeholders and leadership.
• Assesses product and project documentation for compliance and supports change control activities.
• Presents product quality metrics, investigation outcomes, and recommended resolutions to leadership.
• Coordinates Health Risk Assessment activities and supports Quality Investigation Review boards.
• Performs field investigations at customer sites in partnership with sales, service, and field-based teams.

Behavior

• Works collaboratively across functions and takes ownership of investigations and quality issues.
• Demonstrates sound judgment in prioritizing complaints based on risk, trends, data, and business impact.
• Operates with intermediate autonomy, requiring limited oversight on complex issues.
• Shows strong accountability, compliance mindset, and attention to detail.
• Communicates effectively with technical teams, leadership, and field-based partners.
• Applies company policies and procedures consistently to resolve quality and product issues.
• Takes initiative to lead critical tasks and drive timely resolution.

Experience

• Bachelor's degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
• 2–5 years of relevant engineering experience.
• 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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

#LI-NK1