Systems Engineer - Electromechanical Medical Devices
About the job
- 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.
- 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 support design decisions.
- Ensure development follows the governing quality management system and regulatory standards while maintaining a right-sized Design Development File.
- Experience leading cross-functional teams of engineers and designers.
About the company
Engenious Design helps clients develop electronic medical devices and other high-tech systems by integrating with their R&D teams to cover the full product lifecycle, from planning and design to prototyping, verification, and transfer to production while complying with ISO 13485 and FDA 21 CFR 820. It provides end-to-end services including hardware, embedded software, and mechanical engineering with in-house labs and short-run manufacturing capabilities. Unlike others, it embeds its teams within client organizations and offers white-label design and manufacturing, delivering hands-on engineering and seamless production transfer. Its goal is to help customers bring safe, compliant, market-ready devices to market efficiently as their R&D needs grow.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Prairie Village, Kansas
Founded
2007
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Simplify's Take
What believers are saying
- April 2025 expansion tripled capacity, supporting more concurrent client programs.
- August 2026 website updates show nearly 100 employees and continued hiring momentum.
- June-August 2026 PFA articles position Engenious for pulsed-field ablation development work.
What critics are saying
- Project-based consulting revenue depends on client R&D budgets and program cancellations within quarters.
- 2026 PFA-generator content signals broader scope, stretching teams across high-voltage and medical-device work.
- The 2022 UV-LED patent settlement leaves lingering legal and reputational overhang.
What makes Engenious Design unique
- Nearly 100 engineers inside a 56,000-square-foot Prairie Village design center.
- In-house electronics, test, prototype, and short-run production compress medical-device iteration cycles.
- ISO 13485 and 21CFR820 discipline attracts Class II, III, and PMA programs.
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Benefits
Unlimited Paid Time Off
Parental Leave
Flexible Work Hours
Health Insurance
Life Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
401(k) Company Match
Health Savings Account/Flexible Spending Account
Performance Bonus