Principal Engineer, Post Market Surveillance

Johnson & Johnson MedTech

Danvers, Massachusetts, United States
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
Johnson & Johnson MedTech is seeking a Principal Engineer for Post Market Surveillance in Danvers, MA, with options for remote work. The role focuses on overseeing post market surveillance activities, data analysis, and complaint trending, requiring a strong background in medical device regulations and quality management

Job Summary

  • This role is responsible for enabling signal detection, analyzing complaint data trending, escalating trends or issues, and creating annual reports in accordance with procedural guidance.
  • The Principal Engineer will present post market data in various forums and provide support during regulatory inspections to ensure compliance and inspection readiness.
  • Employees are eligible for a comprehensive benefits package including retirement plans, vacation, sick time, parental leave, and volunteer leave.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a Principal Engineer for Post Market Surveillance in Danvers, MA, with options for remote work. The role focuses on overseeing post market surveillance activities, data analysis, and complaint trending, requiring a strong background in medical device regulations and quality management.

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
  • Quality management system experience
  • Strong communication skills
  • Working knowledge of global medical device regulations
  • Ability to work independently

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 statistical methods expertise
  • Experience mentoring or managing complaint trending efforts
  • Ability to travel up to 10%
  • Knowledge of 21 CFR 820, ISO 13485, EU MDR compliance
  • Must work U.S. Eastern Time (EST) hours

Work Rights

Not specified

Tailored Resume

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