Job Description
*** On site 5 days a week in Santa Clara, CA***
Job Description
- Execute process validations (IQ/OQ/PQ), including protocol development and test reporting
- Collaborate with NPI engineering teams to evaluate and prioritize critical test processes during design transfer
- Develop and maintain automated test scripts for data collection and analysis
- Support continuous improvement of test infrastructure and documentation to meet compliance and quality standards
Required Skills & Experience:
- 2+ years of experience in manufacturing test method validation
- Strong understanding of process qualification and validation (IQ/OQ/PQ)
- Background in the medical device industry, with solid understanding of regulatory standards (e.g., PFMEAs, IQ protocols, FDA compliance)
- Proficiency in Python and ideally the Pytest framework
Compensation:
$50.00/hr to $60.00/hr.
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
*** On site 5 days a week in Santa Clara, CA***
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