Software Design Quality Engineer Ii

Johnson & Johnson MedTech

Danvers, Massachusetts, United States
Base: $92,000.00 - $148,350.00; bonus/equity: elig...
Hybrid (minimum of 3 days per week in danvers, ma)
Software development lifecycle support
Risk management activities
Design controls compliance
Johnson & Johnson MedTech is seeking a Software Design Quality Engineer II in Danvers, Massachusetts, to support new product development and ensure compliance with quality standards in medical device software. The ideal candidate should possess experience in quality systems, risk management, and software development methodologies

Job Summary

  • Support quality focused design and development of software within the software development lifecycle by defining requirements, design, verification and validation plans and strategies while maintaining traceability.
  • Drive and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
  • Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of Quality.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a Software Design Quality Engineer II in Danvers, Massachusetts, to support new product development and ensure compliance with quality standards in medical device software. The ideal candidate should possess experience in quality systems, risk management, and software development methodologies.

Salary

Base: $92,000.00 - $148,350.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Software Development Lifecycle support
  • Risk Management activities
  • Design Controls compliance
  • Software as a Medical Device (SaMD)
  • Software in a Medical Device (SiMD)
  • Product cybersecurity activities

Nice-to-have

  • Teamwork and flexibility
  • Self-motivated engineer
  • Excellent written and verbal communication
  • Dynamic, fun, multi-disciplinary team

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Minimum of 2 years related work experience
  • Intermediate knowledge of quality system regulation
  • Intermediate knowledge of SaMD and SiMD systems
  • Intermediate knowledge of software development lifecycle processes

Work Rights

Not specified

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