Bachelor's Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
10+ years of relevant experience with a Bachelor's, 8+ years with a Master's, or 5+ years with a PhD.
Minimum 8 years of direct Post Market experience in medical device quality engineering or a related field.
Hands-on depth in at least two areas: complaint handling, medical device reporting, health risk assessment, or data analysis.
Preferred experience supporting FDA inspections and responding to inspectional observations.
Responsibilities
Lead post-market quality assurance processes to ensure patient safety and regulatory compliance.
Design and improve procedures, decision trees, and technical documentation for PMQA.
Conduct gap assessments and process improvements to enhance quality systems.
Support complex complaint investigations and root cause analyses.
Represent PMQA during inspections and audits, ensuring readiness and compliance.
Evaluate the potential use of AI in post-market processes for risk and validation considerations.
Coach and mentor engineers and specialists to build organizational capability.
Benefits
Comprehensive health insurance plans.
Retirement savings options with company matching.
Generous paid time off and holiday policies.
Opportunities for professional development and training.
Flexible work arrangements to support work-life balance.
Full Job Description
Job Description
The Principal Post Market Quality Engineer serves as the senior technical authority for Post Market Quality Assurance, leading integrated, compliant, and risk-based post-market processes across Breast & Skeletal Health Solutions product lines to ensure patient safety, regulatory compliance, and continuous quality system improvement.
Knowledge
Expert understanding of Post Market Quality Assurance processes across complaint handling, complaint investigation, medical device reporting, reportability, health risk assessment, and post-market data analysis/trending.
Deep knowledge of medical device regulations and quality system requirements, including:
21 CFR Part 820 / QMSR
21 CFR Part 803
21 CFR Part 806
21 CFR Parts 1000-1050
ISO 13485
ISO 14971
EU MDR vigilance requirements
MDSAP
Strong understanding of FDA, Notified Body, and MDSAP inspection expectations.
Knowledge of risk management, health risk assessment, Health Hazard Evaluation, patient impact assessment, and risk acceptability.
Knowledge of how Post Market processes interact with design, manufacturing, CAPA, nonconformance, field actions, and overall quality system remediation.
Understanding of statistical methods, trending, signal detection, and emerging-risk evaluation.
Awareness of evolving global regulations, guidance, and industry practices.
Preferred knowledge of Salesforce-based complaint systems, Agile or other electronic QMS systems, test method validation, design of experiments, and reliability analysis.
Skills
Serves as a senior technical authority and subject matter expert across PMQA processes.
Designs, improves, and governs procedures, decision trees, forms, templates, and technical documentation.
Makes and defends risk-based technical and process decisions under regulatory scrutiny.
Leads gap assessments, remediation activities, process improvements, retrospective reviews, and verification of effectiveness.
Provides technical direction to process leads and cross-functional teams without direct authority.
Supports complex complaint investigations, root cause analysis, escalation decisions, reportability assessments, CAPA, nonconformance, and field action evaluations.
Enhances post-market data analysis, trending, and signal detection methods.
Evaluates potential use of artificial intelligence in Post Market processes, including benefit, risk, validation, and regulatory compliance considerations.
Represents PMQA during inspections and audits, including readiness preparation, storyboards, observation responses, and corrective actions.
Communicates effectively with executives, regulators, inspectors, technical teams, and cross-functional partners.
Coaches, mentors, and trains engineers, specialists, and process leads.
Preferred certifications include ASQ CQE, CRE, or CQA.
Behavior
Acts with complete autonomy and independent judgment on complex, high-risk, or unique assignments.
Demonstrates technical leadership without direct supervisory responsibility.
Operates with urgency to identify, escalate, and resolve quality issues.
Influences without authority and builds credibility with senior leaders, process owners, regulators, and cross-functional partners.
Thinks systemically, ensuring PMQA processes operate as an integrated, compliant, and sustainable system.
Uses sound judgment when evaluating ambiguous data, intangible factors, and regulatory risk.
Maintains consistency in methods, decision criteria, and documentation across processes, sites, and product lines.
Models Hologic and BSHS quality values while protecting patient safety and the Hologic brand.
Builds formal networks across functions to support quality objectives and organizational goals.
Coaches others and builds organizational capability through mentoring and training.
Experience
Bachelor's Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
Advanced degree preferred.
Required experience level:
Bachelor's degree with 10+ years of relevant experience, or
Master's degree with 8+ years of relevant experience, or
PhD with 5+ years of relevant experience.
Experience should be in medical device quality engineering or a related field.
Minimum 8 years of direct Post Market experience.
Hands-on depth required in at least two of the following areas, with working knowledge of all:
Complaint handling and investigation
Medical device reporting
Health risk assessment
Data analysis and trending
Strongly preferred experience supporting FDA inspections and responding to inspectional observations.
Preferred experience with capital equipment, radiation-emitting products, and single-use or sterile devices.
Experience leading or supporting quality system remediation and improvement programs.
Experience providing technical leadership across product lines, sites, and cross-functional teams.
The annualized base salary range for this role is $138,000 - $230,000 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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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.
