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8 дней назад

Senior Equipment Design Engineer (Medical Devices)

104 000 - 156 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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