6 часов назад
Senior Manufacturing Test Engineer (Medical Devices)
110 000 - 135 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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