Principal Engineer, Post Market Surveillance

Johnson & Johnson Innovative Medicine

Danvers, Massachusetts, United States
Base: $102,000.00 - $177,100.00; bonus/equity: not...
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Abiomed post market surveillance processes
Signal detection and trending
Regulatory compliance qsr mdv mdr
** Johnson & Johnson is seeking a Principal Engineer for Post Market Surveillance in Danvers, Massachusetts, with remote work options considered. The role involves overseeing post market surveillance activities, leading complaint trending programs, and ensuring compliance with regulatory standards. **

Job Summary

  • This role enables signal detection, analyzes complaint data trending, escalates trends or issues, and helps create annual reports as needed in accordance with procedural guidance.
  • You will be responsible for subject matter expertise accountable for Abiomed Post Market Surveillance (PMS) activities including leading discussions and presenting PMS data in any required forums.
  • The anticipated base pay range for this position is : $102,000.00 - $177,100.00.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Principal Engineer for Post Market Surveillance in Danvers, Massachusetts, with remote work options considered. The role involves overseeing post market surveillance activities, leading complaint trending programs, and ensuring compliance with regulatory standards. **

Salary

Base: $102,000.00 - $177,100.00; Bonus/Equity: Not specified; Benefits: Vacation –120 hours per calendar year, Sick time - 40-56 hours per calendar year, Holiday pay –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours, Bereavement Leave – 240 hours/40 hours, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours

Skills & Requirements

Must-have

  • Abiomed post market surveillance processes
  • signal detection and trending
  • regulatory compliance QSR MDV MDR
  • post market surveillance data analysis
  • cross-functional collaboration

Nice-to-have

  • mentoring and coaching team members
  • statistical methods and dataset analysis
  • project management knowledge
  • independent work and accountability

Key Requirements

  • BS degree with 6–8 years’ experience
  • 3 years’ direct post market surveillance experience
  • Working knowledge of FDA Medical Device Regulations
  • Strong analytical skills

Work Rights

Not specified

Tailored Resume

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