8 дней назад
Senior Equipment Design Engineer (Medical Devices)
104 000 - 156 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Equipment Design Engineer (Medical Devices): Designing and implementing custom manufacturing equipment, automation systems, tooling, and fixtures for regulated medical device production with an accent on SolidWorks-based mechanical design, equipment validation, and cross-functional system integration. Focus on developing robust and manufacturable equipment, leading design reviews, supporting FAT/SAT and commissioning, and solving tolerance, failure analysis, and root-cause challenges.
Location: Lafayette, Colorado, United States; onsite four days per week
Salary: $104,000–$156,000 USD annually, plus incentive eligibility
Company
develops medical technologies intended to alleviate pain, restore health, and extend life.
What you will do
- Design and develop custom machines, automation systems, tooling, fixtures, and manufacturing equipment for medical device development and production.
- Create and maintain detailed SolidWorks 3D models, assemblies, drawings, bills of materials, and controlled engineering documentation.
- Support equipment qualification, validation, FAT, SAT, commissioning, troubleshooting, and post-installation investigations.
- Collaborate with mechanical, electrical, software, controls, manufacturing, quality, validation, and operations functions.
- Lead and participate in design reviews focused on robustness, manufacturability, maintainability, risk mitigation, and release readiness.
- Perform tolerance stack-ups, failure analysis, root-cause investigations, and design-for-manufacturing and assembly assessments.
Requirements
- Bachelor’s degree with at least four years of relevant experience, or a master’s degree with at least two years of relevant experience, or a PhD with no required experience.
- Experience with machine design, automation, manufacturing equipment, or capital equipment development.
- Advanced SolidWorks proficiency, including complex assemblies, detailed mechanical drawings, and formal design documentation.
- Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.
- Strong knowledge of mechanical design principles, GD&T, tolerance analysis, material selection, and manufacturing processes.
Nice to have
- Experience with robotics, motion control, pneumatics, vision systems, or mechatronics.
- Knowledge of PDM/PLM systems, FEA, and structured engineering change processes.
- Experience designing and validating equipment for medical device manufacturing.
- Experience with IQ/OQ/PQ protocols, test methods, and validation summaries.
- Experience leading technical projects and managing timelines, risks, and deliverables.
Culture & Benefits
- Onsite collaboration and professional development are emphasized through four office days per week.
- Health, dental, vision, life, disability, and flexible spending benefits are available to eligible regular employees.
- Benefits include 401(k) contributions and matching, paid time off, paid holidays, tuition assistance, and employee stock purchase opportunities.
- Regular employees may receive incentive plans and access to well-being and employee assistance programs.
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