Principal Embedded Systems Engineer – Medical Devices (Hybrid)

USA SOLVENTUM US LLC

San Antonio (TX)

Hybrid

USD 124,000 - 171,000

Full time

3 days ago
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Benefits offered by this job

Medical, Dental & Vision
Health Savings Accounts
Life Insurance
Disability Benefits
Retirement Benefits

Job summary

Solventum is seeking a Principal Systems Engineer, Embedded R&D, to drive cross‑functional product development for medical devices. Hybrid work in San Antonio, TX with some remote days and travel up to 10%.

You will shape system requirements, architecture, interfaces and verification plans across Mechanical, Electrical, Software, and Quality teams. You will lead risk management activities, contribute to regulatory submissions and assure design controls in a GMP environment.

Qualifications

  • Bachelor’s degree in engineering and 7+ years in systems engineering in regulated environment.
  • 11+ years experience with HS diploma in regulated systems engineering.
  • 5+ years designing, developing and testing embedded electro‑mechanical medical devices.
  • 5+ years in GMP environments with FDA/ISO‑registered work.
  • 2+ years System Engineering with C/C++, IoT, and cybersecurity risk management.
  • Experience leading requirements, architecture reviews, and V&V.

Responsibilities

  • Advise cross‑functional teams on new product development as technical bridge across disciplines.
  • Define and manage system requirements, architecture, interfaces, and data flows with traceability.
  • Lead system design reviews, evaluate performance, cost, risk and supportability.
  • Support risk management including DFMEA and ISO 14971 requirements.
  • Collaborate with V&V to develop verification strategies against inputs and use.
  • Review technical docs for product development and regulatory submissions (FDA/ISO).
  • Adhere to company policies and drive continuous improvement.

Skills

Embedded systems
Systems engineering
Problem solving
Cross-functional collaboration

Education

Bachelor's degree in engineering
High School Diploma + 11 years experience in regulated environment

Tools

C/C++ embedded systems
IoT communications
Cybersecurity risk management

Job description

Solventum is seeking a Principal Systems Engineer, Embedded R&D, to drive cross‑functional product development for medical devices. Hybrid work in San Antonio, TX with some remote days and travel up to 10%.

You will shape system requirements, architecture, interfaces and verification plans across Mechanical, Electrical, Software, and Quality teams. You will lead risk management activities, contribute to regulatory submissions and assure design controls in a GMP environment.

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