Lead Product Quality Engineer

Hologic•Newark, NJ

1d•$119,300 - $186,600

About The Position

Provide product quality engineering support for on-market medical devices and serve as the product expert for assigned product lines and processes. The role evaluates and investigates post-market feedback and complaints, conducts risk assessments and root cause analyses, and leads cross-functional implementation of improvements or corrections. It also serves as process owner and subject matter expert for Product Quality Engineering processes, ensuring procedures remain compliant, effective, and consistently applied. The role mentors Product Quality Engineers and complaint intake staff, building technical capability and promoting consistent, high-quality investigations. The position leads complaint investigations, Health Risk Assessments, Health Hazard Evaluations, data analysis and trending, and cross-functional changes to product design or manufacturing processes. It provides post-market feedback to Operations, Engineering, and R&D; investigates field issues with customer-facing teams; presents product quality metrics and recommendations to leadership; and participates as a product subject matter expert in audits and inspections. The role works with a high degree of autonomy on complex problems. A bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering and eight or more years of experience are required; the experience threshold is six or more years with a master’s degree or three or more years with a PhD. Experience in an FDA-regulated industry is required. The role is bonus eligible, with an annualized base salary range of $119,300–$186,600.

Requirements

Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering and at least 8 years of experience; 6 or more years with a master’s degree; or 3 or more years with a PhD.
Experience in an FDA-regulated industry.
Demonstrated experience leading root cause analysis and complex complaint investigations.
Demonstrated experience coaching, mentoring, or training engineers or technical staff.
In-depth knowledge of FDA Quality Management System Regulation (21 CFR 820), particularly Design Control requirements; ISO 13485; EU MDR 2017/745; ISO 14971 Risk Management; GMP; and GDP.
Proven ability to lead project teams and take leadership on critical tasks to ensure timely completion and resolution.
Ability to assess written product and project documentation for compliance and communicate assessments effectively.
Strong knowledge of root cause analysis tools and ability to lead and coach root cause activities for complaint investigations, nonconformances, and CAPAs.
Excellent communication and presentation skills, including ability to influence cross-functional partners.
Strong coaching and mentoring skills and ability to develop technical capability in others.
Ability to develop and maintain product knowledge and serve as subject matter expert for assigned product lines.
Ability to manage multiple projects and priorities simultaneously.
Ability to work autonomously with minimal oversight on highly complex problems involving analysis of varied factors.

Nice To Haves

Experience in product development or R&D.
Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment.
Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
Working knowledge of verification and validation requirements for a regulated product.
Familiarity with requirements analysis, including development of testable and measurable specifications.
Knowledge of risk-based and statistical analysis concepts.
ASQ Certified Quality Engineer (CQE) or equivalent.

Responsibilities

Serve as product expert for assigned product lines, building knowledge of design, functionality, clinical use, known failure modes, and applicable risk management documentation.
Own Product Quality Engineering processes and procedures, ensuring compliance, effectiveness, and consistent application.
Train and mentor Product Quality Engineers and complaint intake staff; provide technical guidance and review investigation documentation for quality and compliance.
Lead prioritization, evaluation, documentation, and timely completion of risk-based complaints and investigations.
Lead investigations and root cause analyses, coordinating stakeholder collaboration and communication.
Partner with cross-functional teams to communicate root causes, determine whether CAPA is required, recommend changes, and scope implementation efforts.
Execute Health Risk Assessments and Health Hazard Evaluations and coordinate internal evaluations of on-market product issues.
Analyze and trend complaint and failure-mode data, identify mitigations for threshold risks, and prepare and present findings to stakeholders.
Lead cross-functional implementation of design or process changes, including drawing, fixture, and tooling updates, testing, and change-control documentation as applicable.
Develop or improve testing methods used in complaint investigations and root cause activities.
Assess product changes for effects on design and risk management and determine supporting information needed for implementation.
Provide post-market feedback to Operations, Engineering, and R&D to improve devices in the field and in development.
Lead field investigations at customer sites in partnership with field teams, including sales and service, and urgently resolve field quality issues.
Present product quality metrics, root causes, and recommended actions or resolutions to leadership.
Participate in internal and external audits as a product subject matter expert, including facility and supplier audits and Notified Body and FDA inspections.
Review team inputs for monthly Quality Investigation Review boards and prepare and present materials where applicable.
Perform other function-related activities as reasonably required by business needs.