Product Engineer I

Product Engineer I Astrix Technology Group - 3.4 Houston, TX Job Details Contract 15 hours ago Benefits Health insurance Dental insurance Paid time off 401(k) matching Qualifications Statistics Production data analysis Defect resolution root cause analysis Quality control product testing Quality control statistical data analysis Preventive action implementation Regulatory compliance Statistical Process Control Production deviation management Biomedical Engineering Corrective and preventive actions (CAPA) Mid-level Statistical analysis Production validation processes Quality risk management Master of Science Biomedical regulatory compliance Engineering functional testing 1 year Functional quality evaluation testing Cross-functional collaboration Manufacturing company experience Communication skills Product quality failure Cross-functional communication Failure analysis Full Job Description Exciting Product Engineer development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in

Surgical and Vision Care Contract:

2-Year Contract - Extension or conversion potential

Benefits:

Medical, Dental, Holiday, PTO 401K matching Product Engineer I Supports cross-functional teams in validation activities from design through implementation. Executes

IQ/OQ/PQ

testing and investigates validation discrepancies and process issues. Develops change controls, supports root cause analysis, and evaluates CAPAs for effectiveness. Ensures compliance with regulatory and internal quality requirements. Applies statistical analysis to assess process control, manage product quality risks, and support non-conformance decisions.

Qualifications:

1-10 years experience in an engineering or scientific R D or manufacturing environment preferred. Masters of Science in Biomedical Engineering or scientific discipline preferred. Experience in validation within a regulated industry (medical device, pharmaceutical, biotech, or similar) Working knowledge of

IQ/OQ/PQ

protocols and validation lifecycle requirements Familiarity with CAPA, change control, and deviation/non-conformance systems Strong understanding of statistical analysis for quality and process control Excellent communication and collaboration skills in cross-functional environments This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! INDBH #LI-RL1