The Role
The Systems Engineer will drive product development by integrating electrical, mechanical, and software disciplines, managing risks, and ensuring compliance with standards in creating medical devices.
Summary Generated by Built In
We’re seeking an experienced product development Systems Engineer who can think big-picture while staying hands-on across diverse technologies. You’ll define user needs, drive system‑level requirements, and unite electrical, mechanical, and software disciplines into cohesive products. Acting as the connective tissue across designers, engineers, and clients, you’ll navigate tradeoffs, manage risk, and tackle complex integration challenges to deliver life‑changing medical and high‑tech products.
What You’ll Do:
Position Details:
This is a full-time, permanent position. This leadership position is based in our Kansas City design center, and not available as a remote job.
Qualifications:
While we recognize that top talent comes from all over the world, we are a small team and are not able to offer visa sponsorship at this time. Candidates must be authorized to work in the United States without requiring visa sponsorship
What You’ll Do:
- Maintain the System View: Act as the holistic thinker for the product—maintaining a clear mental model of the system, identifying roadblocks early, and guide the team toward effective solutions.
- Lead Cross-Functional Integration: Coordinate electrical, mechanical, software, industrial design, and test workstreams to ensure the product functions as a cohesive system.
- Drive Requirements & Traceability: Lead the definition of user needs and product requirements, maintaining clear traceability from requirements to design decisions, risk management, and verification.
- Own Risk Management: Proactively identify, prioritize, document, and manage technical and program risks, working closely with the design team to develop and execute mitigation strategies.
- Act as a Technical Investigator: Use prototypes, proof-of-concept builds, and engineering testing to validate concepts and inform design direction.
- Enable Informed Decisions: Communicate system architecture, progress, risks, and tradeoffs clearly to teams and clients, empowering confident design decisions.
- Guide Compliance & Documentation: Ensure development follows the governing QMS and regulatory standards while maintaining a right-sized Design Development File.
Position Details:
This is a full-time, permanent position. This leadership position is based in our Kansas City design center, and not available as a remote job.
Qualifications:
- 5+ years of applicable experience in electromechanical/embedded system product development
- Experience with medical device standards such as ISO 60601-1, ISO 13485 etc., or similar experience in a regulated industry
- Experience leading cross-functional teams of engineers and designers
While we recognize that top talent comes from all over the world, we are a small team and are not able to offer visa sponsorship at this time. Candidates must be authorized to work in the United States without requiring visa sponsorship
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The Company
What We Do
Our engineering team is a booster rocket for accelerating medical device design; we help clients launch products with certainty. We fold into client development teams, working alongside as design partners. Our uniquely-integrated approach means lower-risk development and more transparency. Our team’s portfolio includes FDA Class II, III and PMA devices. We plan, specify, architect, design, prototype, verify, validate and transfer devices to production. Our focus is on electronic, mechanical and embedded software medical devices. Because of our medical device focus, we have an ISO:13485 / 21CFR820 - compliant quality system.
