Principal Systems Engineer - Hybrid - San Antonio, Tx

Solventum

San Antonio, Texas, US
Base: $124,000 - $170,500; bonus/equity: variable ...
Hybrid
Systems engineering in regulated environment
Embedded electro-mechanical medical device design
Iso 14971 risk management and dfmea
Solventum is a new healthcare company dedicated to solving big challenges that improve lives through innovation at the intersection of health, material, and data science

Job Summary

  • Solventum is a new healthcare company dedicated to solving big challenges that improve lives through innovation at the intersection of health, material, and data science.
  • The Principal Systems Engineer will define system boundaries, manage risks via ISO 14971, and author technical files for global regulatory submissions like FDA 510(k).
  • This hybrid role requires working from San Antonio, TX at least three days per week while collaborating with diverse teams to resolve design conflicts.

Matching Summary

Solventum is a new healthcare company dedicated to solving big challenges that improve lives through innovation at the intersection of health, material, and data science.

Salary

Base: $124,000 - $170,500; Bonus/Equity: Variable incentive pay eligible; Benefits: Medical, Dental, Vision, HSA, Retirement

Skills & Requirements

Must-have

  • Systems Engineering in regulated environment
  • Embedded electro-mechanical medical device design
  • ISO 14971 risk management and DFMEA
  • FDA 510(k) or PMA regulatory documentation
  • C or C++ embedded systems knowledge
  • Cybersecurity risk management experience
  • GMP certified manufacturing processes

Nice-to-have

  • IEC 60601-1 standard experience
  • Graphical User Interface development skills
  • Wireless communications expertise
  • Continuous improvement process driving
  • Cross-functional team leadership

Key Requirements

  • Bachelor's degree in engineering AND 7 years experience
  • High School Diploma/GED AND 11 years experience
  • Experience in FDA or ISO registered work environment
  • Must be legally authorized to work without sponsorship

Work Rights

Must be legally authorized to work without sponsorship

Tailored Resume

Cover Letter