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2 часа назад

Staff Manufacturing Engineer (Medical Devices)

140 000 - 180 000$
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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Текст:
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TL;DR
Staff Manufacturing Engineer (Medical Devices): Leading manufacturing engineering for complex electromechanical assemblies and scalable production processes for an AI- and robotics-enabled medical platform with an accent on manufacturing transfers, contract manufacturer partnerships, and production readiness. Focus on developing manufacturing packages, validating processes, transferring tooling and fixtures, and improving quality, yield, delivery, capacity, cycle time, and cost across a regulated medical-device manufacturing network.

Location: On-site at hirify.global HQ in San Mateo, California, United States; domestic and international travel to suppliers and contract manufacturers required.

Annual salary: $140,000–$180,000.

Company

hirify.global develops a medical technology platform combining real-time imaging, robotics, and artificial intelligence to make precise interventions more accessible.

What you will do

  • Lead manufacturing engineering for complex electromechanical assemblies and own the technical relationship with contract manufacturing partners.
  • Plan and execute manufacturing transfers between internal production and external partners and between contract manufacturing sites.
  • Partner with R&D on DFM/DFA, manufacturing strategies, and readiness of new assemblies for external production.
  • Develop and transfer manufacturing packages, tooling, fixtures, process flows, work instructions, routings, and inspection plans.
  • Lead pilot builds, process characterization, IQ/OQ/PQ validation, production readiness reviews, and manufacturing ramp activities.
  • Improve quality, yield, delivery, capacity, cycle time, and cost while monitoring manufacturing risks and performance metrics.

Requirements

  • Bachelor’s degree in mechanical engineering, manufacturing engineering, electrical engineering, or a related technical field.
  • 8+ years of experience in manufacturing engineering, NPI, industrialization, supplier manufacturing, or a related discipline.
  • Experience transferring complex electromechanical assemblies and qualifying or onboarding contract manufacturers.
  • Strong knowledge of assembly, tooling, fixtures, test equipment, inspection methods, process controls, DFM/DFA, root-cause analysis, corrective action, process capability, and SPC.
  • Experience with manufacturing documentation, pilot builds, process validation, production readiness, and manufacturing ramps.
  • Experience manufacturing FDA-regulated medical devices or products in a highly regulated industry; experience with Linux and manufacturing software.

Culture & Benefits

  • Cross-functional collaboration with R&D, Operations, Supply Chain, Quality, and external manufacturing partners.
  • Medical, dental, and vision coverage.
  • 401(k) plan with company match.

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