Principal Systems Engineer, Embedded R&D

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

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

Job Description: Principal Systems Engineer, Embedded R&D 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As a Principal Systems Engineer, Embedded R&D, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

Here, you will make an impact by:

  • Advising cross-functional teams on new product development, serving as the technical bridge across Mechanical, Electrical, Software, Quality, and V&V teams.
  • Defining and managing system requirements, architecture, interfaces, and data flows while ensuring end-to-end requirements traceability.
  • Leading technical planning, system design and architecture reviews, evaluating alternatives based on performance, cost, risk, and supportability.
  • Supporting risk management activities, including Hazard Analysis, DFMEA, usability, and ISO 14971 requirements.
  • Collaborating with V&V teams to develop and execute verification and validation strategies against design inputs and intended use.
  • Reviewing technical documentation supporting product development and global regulatory submissions, including FDA 510(k), PMA, and EU MDR.
  • Participating in all reasonable work activities deemed suitable and assigned by management.
  • Conforming to, supporting and enforcing all Company policies and procedures.
Qualifications
  • Bachelor’s degree or higher (completed and verified prior to start) in engineering from an accredited institution AND minimum of seven (7) years combined industry experience in systems engineering and/or product design in a regulated environment
  • High School Diploma/GED (completed and verified prior to start) and eleven (11) years combined industry experience in systems engineering and/or product design in a regulated environment
  • Five (5) years Demonstrated understanding and experience in design, development, and testing of embedded, electro‑mechanical medical devices.
  • Five (5) years experience in a regulated design environment with medical device development, FDA or ISO registered work experience.
  • Five (5) years Experience in GMP certified Manufacturing Processes and UL/IEC Standards.
  • Two (2) years of hands‑on experience in System Engineering with products that include C or C++ embedded systems, IoT Communication, and/or Cybersecurity risk management.
  • Experience leading system requirements, architecture, integration, and testing through formal design reviews to final verification and validation.
  • Experience facilitating technical working sessions and engineering reviews.
  • Proven experience Identifying, quantifying, and mitigating technical risks.
  • Strong self-directed execution, problem solving and critical thinking skills
  • Experience with Graphical User Interface development.
  • Experience with wireless communications (Cellular, Bluetooth, WiFi) and/or location services (GPS).
  • Experience driving continuous improvement of processes, tooling, and technical deliverables.

Work location: San Antonio, TX- Hybrid (Job Duties allow for some remote work but require travel to San Antonio, TX at least 3 days per week).

Travel: May include up to 10% domestic / international.

Relocation Assistance: May be authorized.

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well‑Being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Applicable to US Applicants Only: The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience.

  • Medical, Dental & Vision
  • Health Savings Accounts
  • Health Care & Dependent Care Flexible Spending Accounts
  • Disability Benefits
  • Life Insurance
  • Voluntary Benefits
  • Paid Absences and Retirement Benefits

Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is an equal opportunity employer.

Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

About Solventum

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges. 20,000+ employees worldwide. Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them. Healthcare that leads with heart and humility starts with listening and never finishes, only evolves. As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work. Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives. In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders. To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future.

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