Principal Systems Engineer, Embedded R&D

3mcompany; San Antonio (TX); Hybrid; USD 124,000 - 171,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Solventum in the United States is seeking a Principal Systems Engineer, Embedded R&D to lead cross-disciplinary product development for medical devices. You will define requirements, architect systems, and drive end-to-end verification with V&V teams in a hybrid San Antonio setting.

Qualifications include 7+ years in regulated engineering, strong C/C++ embedded experience, and familiarity with FDA/ISO processes.

Qualifications

• Engineering degree with 7+ years systems engineering in regulated environments.
• 5+ years in embedded electro-mechanical medical devices.
• 5+ years in GMP manufacturing and UL/IEC standards.
• 2+ years in system engineering with C/C++ embedded, IoT, or cybersecurity.
• Experience with FDA/ISO regulatory submissions and V&V.

Responsibilities

• Advise cross-functional teams on new product development across Mechanical, Electrical, Software, Quality, and V&V.
• Define and manage system requirements, architecture, interfaces, data flows with traceability.
• Lead design reviews and assess alternatives for performance, cost, risk, and supportability.
• Support risk management incl. Hazard Analysis, DFMEA, usability, ISO 14971.
• Collaborate with V&V to develop verification and validation strategies.
• Review documentation for regulatory submissions (FDA 510(k), PMA, EU MDR).

Skills

Embedded systems

C/C++ programming

IoT communications

Cybersecurity risk management

Regulated environment experience

Education

Engineering degree (Bachelor’s or higher)

High School Diploma with 11+ years experience in systems engineering

Tools

FDA/ISO regulatory submissions knowledge

V&V processes

C/C++ embedded systems experience

Job description

Principal Systems Engineer, Embedded R&D### Principal Systems Engineer, Embedded R&DApply: Hybrid: US, Texas, San Antonio: United States and Canada: Full time: Posted Today: R01135145At 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.**Your Skills and Expertise**To set you up for success in this role from day one, Solventum requires (at a minimum) the following 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 OR * 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 In addition to the above requirements, the following are also required:AND* 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.Additional qualifications that could help you succeed in this role include: * 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. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). 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 committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of **@solventum.com**. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.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.**Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.**