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 presenting post market data in various forums.
  • Employees are eligible for comprehensive benefits 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 plans, 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
  • Cross-functional collaboration
  • Inspection readiness support

Nice-to-have

  • Mentoring and coaching team members
  • Project management knowledge
  • Strong written and verbal communication
  • Quality management system experience
  • Ability to work independently
  • Knowledge of quality performance metrics

Key Requirements

  • Minimum BS degree
  • 6–8 years relevant professional experience
  • 3 years direct post market surveillance experience
  • Experience with internal and external audits
  • Ability to travel 10% domestically and internationally
  • Knowledge of FDA 21 CFR Part 820 and ISO 13485
  • Must work U.S. Eastern Time (EST) hours

Work Rights

Not specified

Tailored Resume

Cover Letter