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6 часов назад

Senior Manufacturing Test Engineer (Medical Devices)

110 000 - 135 000$
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 Manufacturing Test Engineer (Medical Devices): Developing and validating automated manufacturing test systems for the iLet Bionic Pancreas with an accent on Python-driven test software, hardware integration, and equipment validation. Focus on leading FAT/SAT and IQ/OQ/PQ activities, troubleshooting system-level issues, improving manufacturing yield, and ensuring FDA, ISO 13485, and GMP compliance.

Location: Onsite at the office in Irvine, California, United States. Up to 5% travel may be required.

Salary: $110,000–$135,000 per year

Company

hirify.global is a medical technology company developing type 1 diabetes management solutions, including the iLet Bionic Pancreas.

What you will do

  • Lead the design, development, and validation of manufacturing test methods, fixtures, and automated test systems.
  • Architect and maintain Python-based software for data acquisition, test execution, equipment control, and analysis.
  • Integrate DAQ systems, sensors, PLCs, and other test hardware with software platforms.
  • Define test strategies for new product introduction and production scale-up, driving automation and standardization across manufacturing lines.
  • Lead FAT, SAT, installation, commissioning, and the IQ/OQ/PQ validation lifecycle.
  • Troubleshoot hardware, software, and process issues; analyze manufacturing data to improve yield and reduce costs; collaborate with R&D, Quality, Manufacturing, and leadership.

Requirements

  • Bachelor’s degree in Electrical, Mechanical, Biomedical, Computer Engineering, or a related field; a master’s degree is preferred.
  • 5–8+ years of manufacturing test engineering experience.
  • Advanced Python programming experience for test automation, data analysis, and equipment control.
  • Strong experience leading FAT, SAT, and IQ/OQ/PQ validation activities.
  • Deep knowledge of DAQ systems, sensors, PLCs, automation, and test equipment.
  • Strong problem-solving, root cause analysis, technical leadership, and cross-functional communication skills.

Nice to have

  • Experience designing custom automated equipment and test platforms.
  • Data analytics and visualization experience with Python, SQL, and Pandas.
  • Experience with MES systems, digital manufacturing integration, medical devices, or other highly regulated industries.
  • Lean or Six Sigma certification, preferably Black Belt.

Culture & Benefits

  • Mission-driven, collaborative environment with significant ownership and empowerment.
  • Medical and dental coverage.
  • FSA and HSA plan options, including an annual company HSA contribution.
  • 401(k) program with employer match.
  • Vacation accrual and paid holidays.

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