Engenious Design

Medical device design and engineering partner

Systems Engineer - Electromechanical Medical Devices

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours

Full-timePrairie Village, KS, USANo salary listed

About the Job

Requirements

At least 5 years of applicable experience in electromechanical or embedded system product development.
A degree in a relevant engineering background, such as biomedical, mechanical, electrical, or software engineering, or equivalent experience.
Experience interpreting and applying medical device standards such as IEC 60601-1 and ISO 13485.

Responsibilities

Maintain a holistic system view of the product, identify roadblocks early, and guide the team toward effective solutions.
Coordinate electrical, mechanical, software, industrial design, and test workstreams to ensure the product functions as a cohesive system.
Lead the definition of user needs and product requirements, maintaining traceability from requirements to design decisions, risk management, and verification.
Identify, prioritize, document, and manage technical and program risks, and work with the design team to develop and execute mitigation strategies.
Use prototypes, proof-of-concept builds, and engineering testing to validate concepts and inform design direction.
Communicate system architecture, progress, risks, and tradeoffs clearly to teams and clients to enable informed design decisions.
Ensure development follows the governing quality management system and regulatory standards while maintaining a right-sized Design Development File.

Desired Qualifications

Experience leading cross-functional teams of engineers and designers.

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 IEC 60601-1, 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

About the Company

Engenious Design

Medical device design and engineering partner

Engenious Design provides product design and engineering services for electronic medical devices and other high-technology systems. It works by embedding its teams with client R&D departments to cover planning, design, prototyping, verification, validation, and production transfer under ISO 13485 / 21 CFR 820, for devices including FDA Class II, III, and PMAs. The company combines in-house electronics labs, test labs, prototyping, and short-run manufacturing to deliver end‑to‑end hardware, embedded software, and mechanical engineering, including white-label design services. Its differentiation comes from acting as collaborative design partners within client teams and offering integrated transfer-to-production capabilities, with accomplishments across medical devices and complex systems like Blue Origin’s battery projects. Engenious Design aims to help clients bring safe, compliant, market-ready products to life efficiently while scaling R&D as needed.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Prairie Village, KS
Founded: 2007

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