Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or Biomechanical preferred).
2-5 years of relevant engineering experience.
Experience in an FDA-regulated industry is preferred.
Background in root cause analysis, product development, R&D, or medical device quality engineering is beneficial.
Experience with post-market medical devices, complaint investigations, and CAPA evaluation is preferred.
Responsibilities
Conduct complaint evaluations and investigations for on-market medical devices.
Lead cross-functional teams to implement corrective actions and improvements.
Communicate findings and recommended changes to stakeholders and leadership.
Assess product documentation for compliance and support change control activities.
Present quality metrics and investigation outcomes to leadership.
Coordinate Health Risk Assessment activities and support Quality Investigation Review boards.
Perform field investigations at customer sites in collaboration with sales and service teams.
Benefits
Opportunity for professional growth in a dynamic field.
Engagement with cross-functional teams to enhance product quality.
Involvement in impactful investigations that directly affect patient safety.
Access to continuous improvement initiatives and training opportunities.
Full Job Description
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.
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.
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.
#LI-NK1
About Hologic
Hologic, Inc. is an American medical technology company that develops and manufactures diagnostic products, medical imaging systems, and surgical products. The company's products are used in a wide range of medical applications, including breast cancer screening, cervical cancer screening, and osteoporosis diagnosis. Hologic is headquartered in Marlborough, Massachusetts, and has operations in North America, Europe, and Asia. The company was founded in 1985 and has grown to become one of the largest medical technology companies in the world.
