Lead Product Quality Engineer (Medical Devices)

Location: Newark, DE, United States

Annual base salary: $119,300–$186,600, bonus eligible.

Company

hirify.global develops and manufactures medical devices and operates in an FDA-regulated environment.

What you will do

• Serve as the product expert and process owner for assigned product lines and Product Quality Engineering processes.
• Lead post-market complaint evaluations, complex investigations, root cause analysis, Health Risk Assessments, Health Hazard Evaluations, and risk-based prioritization.
• Coordinate cross-functional teams to determine CAPA needs and implement design, process, drawing, tooling, testing, and change-control improvements.
• Analyze and trend complaint and failure-mode data, identify mitigations, and present quality metrics, root causes, and recommendations to internal stakeholders and leadership.
• Develop and improve testing methods used for complaint investigations and root cause activities, and provide post-market feedback to Operations, Engineering, and R&D.
• Mentor Product Quality Engineers and complaint intake staff, support field investigations at customer sites, and participate as a subject matter expert in audits and FDA or Notified Body inspections.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering; 8+ years of experience with a bachelor’s degree, 6+ years with a master’s degree, or 3+ years with a PhD.
• Experience in an FDA-regulated industry.
• Demonstrated experience leading root cause analysis and complex complaint investigations. Product development or R&D experience is beneficial.
• Experience coaching, mentoring, or training engineers or technical staff.
• In-depth knowledge of FDA Quality Management System Regulation 21 CFR 820, Design Controls, ISO 13485, EU MDR 2017/745, ISO 14971 Risk Management, GMP, and GDP.
• Ability to lead project teams, manage critical tasks, assess 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 the ability to influence cross-functional partners; strong coaching and mentoring skills.
• Ability to maintain product knowledge as a subject matter expert, manage multiple priorities, and work autonomously on highly complex problems.

Nice to have

• Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiments.
• Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Working knowledge of verification and validation requirements for regulated products.
• Familiarity with requirements analysis and development of testable, measurable specifications.
• Knowledge of risk-based and statistical analysis concepts.
• ASQ Certified Quality Engineer certification or equivalent.

Culture & Benefits

• Comprehensive training is provided upon joining.
• Continued development and training are available throughout the career.
• The role is bonus eligible.
• Equal employment opportunity is provided without regard to protected characteristics.