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 analysis
Regulatory compliance with fda and iso standards
This role enables signal detection, analyzes complaint data trending, escalates trends or issues, and helps create annual reports in accordance with procedural guidance

Job Summary

  • This role enables signal detection, analyzes complaint data trending, escalates trends or issues, and helps create annual reports in accordance with procedural guidance.
  • The position provides support during regulatory inspections and ensures post market surveillance information is inspection-ready and compliant with applicable regulations.
  • Employees are eligible for comprehensive benefits including retirement plans, vacation, sick time, parental leave, and various other leave options.

Matching Summary

This role enables signal detection, analyzes complaint data trending, escalates trends or issues, and helps create annual reports in accordance with procedural guidance.

Salary

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

Skills & Requirements

Must-have

  • Post Market Surveillance expertise
  • Complaint trending analysis
  • Regulatory compliance with FDA and ISO standards
  • Statistical and trend analysis skills
  • Quality management of medical devices
  • Presentation of surveillance data

Nice-to-have

  • Mentoring and coaching team members
  • Project management knowledge
  • Cross-functional collaboration
  • Strong written and verbal communication
  • Work independently with accountability
  • Knowledge of global regulatory requirements

Key Requirements

  • Minimum BS degree with 6–8 years relevant experience
  • At least 3 years direct post market surveillance experience
  • Experience fulfilling audit requests
  • Demonstrated expertise in statistical methods
  • Ability to travel 10% domestically and internationally
  • Strong knowledge of 21 CFR 820, ISO 13485, EU MDR
  • Must work U.S. Eastern Time hours

Work Rights

Not specified

Tailored Resume

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