Principal Post Market Quality Engineer (Medical Devices)

Location: Newark, DE, United States, or Marlborough, MA, United States

Annual base salary: $138,000–$230,000, plus bonus eligibility.

Company

hirify.global develops medical technologies and solutions, including products in Breast & Skeletal Health Solutions.

What you will do

• Serve as the senior technical authority for post-market quality assurance across product lines.
• Design, improve, and govern complaint handling, investigation, reportability, health risk assessment, and post-market data processes.
• Lead gap assessments, remediation programs, retrospective reviews, process improvements, and effectiveness verification.
• Provide technical direction for complaint investigations, root cause analysis, CAPA, nonconformance, and field action evaluations.
• Enhance data trending, signal detection, and emerging-risk evaluation, including assessment of artificial intelligence applications.
• Represent post-market quality during FDA, Notified Body, and MDSAP inspections and audits.

Requirements

• Bachelor’s degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
• 10+ years of relevant experience with a bachelor’s degree, 8+ years with a master’s degree, or 5+ years with a PhD.
• At least 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 and investigation, medical device reporting, health risk assessment, or data analysis and trending.
• Knowledge of 21 CFR Parts 803, 806, and 1000–1050, QMSR, ISO 13485, ISO 14971, EU MDR vigilance, and MDSAP.
• Role location: Newark, Delaware, or Marlborough, Massachusetts, United States.

Nice to have

• Advanced degree and ASQ CQE, CRE, or CQA certification.
• Experience supporting FDA inspections and responding to inspectional observations.
• Experience with capital equipment, radiation-emitting products, and single-use or sterile devices.
• Experience with Salesforce-based complaint systems, Agile or other electronic QMS platforms, test method validation, design of experiments, or reliability analysis.

Culture & Benefits

• Comprehensive onboarding training and continued professional development throughout the career.
• Opportunity to coach and mentor engineers, specialists, and process leads.
• Work includes cross-functional collaboration with executives, regulators, inspectors, technical teams, and process owners.
• Annual base salary is bonus eligible.