4 дня назад
Prin Hardware System Engineer (Medical Devices)
140 800 - 211 200$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Prin Hardware System Engineer (Medical Devices): Developing and integrating electrical hardware systems for regulated medical device products with an accent on system-of-systems architecture, traceability, safety, and clinical requirements. Focus on leading subsystem development, validating products against medical device standards, coordinating cross-functional teams, and delivering portfolio-level integrations including connectivity and AI.
Location: Onsite in Lafayette, Colorado, United States
Salary: $140,800–$211,200 per year
Company
develops healthcare technologies designed to alleviate pain, restore health, and extend life.
What you will do
- Lead collaboration among subsystem owners and align functional design interfaces, timelines, budgets, and technical commitments.
- Translate product concepts into fully functional and tested medical device systems in collaboration with Product Owners.
- Define applicable medical device standards and coordinate testing, validation, technical documentation, and traceability.
- Review schematics, PCBA layouts, component selections, and 3D CAD assemblies within integrated system builds.
- Coordinate software, mechanical, electrical, manufacturing, and external design partners to deliver integrated products.
- Track risks and findings, support stage-gate reviews, and contribute to connectivity and AI initiatives through product release and launch.
Requirements
- 7+ years of experience in medical device systems, digital, or software development.
- Experience with at least 3 system-level product or portfolio releases.
- Ability to understand complex system behavior, engineering problems, and constraints across electrical hardware, mechanical systems, software, and integration.
- Experience documenting technical inputs, design outputs, and traceability in Polarion or similar tools.
- Knowledge of standards including IEC 60601, ISO 62304, and ANSI C63.27.
- Unrestricted U.S. work authorization is required for roles below the Principal level; U.S. sponsorship is limited to Principal-level roles and above.
Nice to have
- Experience with Agile methodology.
- Experience in a regulated product industry.
- Strong design portfolio demonstrating previous design work.
Culture & Benefits
- Full-time onsite work within a global healthcare technology organization.
- Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
- 401(k) plan with employer contribution and match, paid time off, and paid holidays.
- Tuition assistance, employee stock purchase plan, incentive plans, and well-being resources.
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