Systems Engineer (Electromechanical Medical Devices)

Engenious Design; Prairie Village (KS); On-site; USD 110,000 - 170,000; Full time

Job summary

Engenious Design in Kansas City seeks a seasoned Systems Engineer for electromechanical medical devices to define user needs and drive system requirements across electrical, mechanical, and software disciplines. You will unite teams, manage risk, and validate concepts through prototypes and testing.

This full-time, on-site role focuses on traceability, regulatory compliance, and Design History File integrity in a high-stakes medical device environment.

Qualifications

• 5+ years in electromechanical/embedded system development.
• Experience with medical device standards (IEC 60601-1, ISO 13485).
• Strong systems engineering fundamentals and risk management.

Responsibilities

• Maintain a holistic system view across electrical, mechanical, and software domains.
• Lead cross‑functional integration and ensure traceability from requirements to design decisions.
• Identify and mitigate technical and program risks in a regulated environment.
• Ensure compliance with QMS and regulatory standards.

Skills

Systems thinking

Cross‑functional collaboration

Requirements traceability

Education

Engineering degree in relevant field

Job description

Systems Engineer (Electromechanical Medical Devices)

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:

• 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
• Degree in a relevant engineering background (e.g Biomedical, Mechanical, Electrical, Software), or equivalent experience.
• Experience interpreting and applying medical device standards such as IEC60601-1, ISO 13485 etc.

Nice to haves:

• 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