Software Design Quality Engineer Ii

J&J FAMILY OF COMPANIES

Danvers, Massachusetts, United States of America
Base: $92,000.00 - $148,350.00; bonus/equity: elig...
Hybrid
Bachelor's degree in engineering or science
2 years related work experience
Iec 62304 compliance knowledge
This role supports New Product Development and sustaining activities for medical devices used in chronic heart failure patients

Job Summary

  • This role supports New Product Development and sustaining activities for medical devices used in chronic heart failure patients.
  • The engineer will drive risk management activities including Hazard Analyses and Software Failure Modes and Effects Analysis (SFMEA).
  • Employees are eligible for a comprehensive benefits package including 120 hours of vacation, parental leave, and long-term incentive programs.

Matching Summary

This role supports New Product Development and sustaining activities for medical devices used in chronic heart failure patients.

Salary

Base: $92,000.00 - $148,350.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: 120 hours vacation, 40-56 hours sick time, 13 holiday days, 480 hours parental leave

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or science
  • 2 years related work experience
  • IEC 62304 compliance knowledge
  • Risk management and SFMEA expertise
  • Agile/Waterfall/DevOps lifecycle experience

Nice-to-have

  • Experience with JAMA and Atlassian tools
  • Cybersecurity in regulated industry background
  • New product development experience
  • Strong written and verbal communication skills
  • Self-motivated team player attitude

Key Requirements

  • Minimum Bachelor's degree required
  • Minimum 2 years of related experience
  • Knowledge of 21 CFR Part 820 and ISO 14971

Work Rights

Not specified

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