Software Design Quality Engineer Ii

Johnson & Johnson

Danvers, Massachusetts, United States of America
Base: $92,000.00 - $148,350.00; bonus/equity: not ...
Hybrid
Software as a medical device (samd)
Software in a medical device (simd)
Iec 62304 compliance
Support quality focused design and development of software within the software development lifecycle by defining requirements, design, verification and validation plans and strategies

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.
  • 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 in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.

Matching Summary

Support quality focused design and development of software within the software development lifecycle by defining requirements, design, verification and validation plans and strategies.

Salary

Base: $92,000.00 - $148,350.00; Bonus/Equity: Not specified; Benefits: Eligible for Company’s consolidated retirement plan (pension) and savings plan (401(k)), long-term incentive program, 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 as a Medical Device (SaMD)
  • Software in a Medical Device (SiMD)
  • IEC 62304 compliance
  • Risk management activities
  • Product cybersecurity activities

Nice-to-have

  • Agile/waterfall/SAFe/DevOps lifecycle
  • JAMA and Atlassian suite
  • Teamwork and flexibility
  • Self-motivated engineer

Key Requirements

  • Bachelor's degree in engineering or scientific discipline
  • Minimum of 2 years of 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

Tailored Resume

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