Principal Engineer, Post Market Surveillance

Johnson & Johnson

Danvers, Massachusetts, United States of America
Base: $102,000.00 - $177,100.00; bonus/equity: not...
Fully remote
Post market surveillance expertise
Complaint trending program leadership
Regulatory compliance with fda and international standards
This role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes

Job Summary

  • This role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes.
  • The position includes mentoring team members, leading complaint trending efforts, and ensuring compliance with applicable quality and regulatory standards.
  • Employees are eligible for a comprehensive benefits package including retirement plans, vacation, sick time, parental leave, and volunteer leave.

Matching Summary

This role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes.

Salary

Base: $102,000.00 - $177,100.00; Bonus/Equity: Not specified; Benefits: Retirement plan, vacation, sick time, parental leave, volunteer leave

Skills & Requirements

Must-have

  • Post Market Surveillance expertise
  • Complaint trending program leadership
  • Regulatory compliance with FDA and international standards
  • Statistical and trend data analysis
  • Quality management of medical devices
  • Presentation of surveillance data
  • Cross-functional collaboration

Nice-to-have

  • Mentoring and coaching team members
  • Project management knowledge
  • Strong written and verbal communication
  • Working knowledge of global regulatory inspections
  • Ability to work independently
  • High reliability and integrity

Key Requirements

  • Minimum BS degree
  • 6–8 years relevant professional experience
  • 3 years direct post market surveillance experience
  • Experience with audits and statistical methods
  • Ability to travel 10% domestically and internationally
  • Knowledge of 21 CFR 820, ISO 13485, EU MDR
  • Work U.S. Eastern Time hours

Work Rights

Not specified

Tailored Resume

Cover Letter