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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…