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ESR Healthcare

Senior Process Development Engineer- Req #2200 River Oaks, CA

ESR Healthcare, River Oaks, California, United States,


Senior Process Development Engineer - Req #2200Location:

River Oaks, CAType:

Full TimeAbout the Company:

Our client has a legacy of innovation to transform next-generation sequencing and its application. They rank among the world’s foremost corporations providing innovative healthcare solutions, continuously investing in medical research and development. If you want to advance your career with a leader, consider applying.Responsibilities:

Develop an integrated manufacturing process and maintain shipping and procedural relationships with vendors.Lead Quality compliance, MGF system Test, and process improvement projects.Execute failure analysis investigations, risk impact assessments, and root cause investigations.Perform failure analysis, risk, and root cause analysis.Create technical documents, including IQ/OQ/PQ, SOPs, URS, Design and Functional Specification, Executed FAT, and Site Acceptance Testing (SAT) verification, as well as final reports.Coordinate internal and external resources for product transfer.Support fixture developers to design and implement new or improved MFG tools/fixtures into supplier manufacturing lines.Collaborate with design engineers to generate cavitation requirements for production tooling and generate reports.Create incoming and outgoing inspection documents/procedures and apply them at suppliers.Devise continuous improvement plans (CIP) and design for manufacturability (DFM) projects for quality improvement and cost reduction.Develop SPC tracking, yield Pareto charts, and other metrics in collaboration with Yield Engineering.Lead field and internal investigations.Craft process recipe matrices in support of yield, reliability, efficiency, and quality improvements.Qualifications:

B.S. in Engineering, Mechanical, Electrical, Chemical, or related field with a minimum of 3 years of experience.2-5 years of related experience.Knowledge of lab equipment and instruments involving liquids and gases (Preferred).Experience with fluid and pneumatic circuits from schematics readings, P&ID’s troubleshooting, components assembly, and testing including microcontroller and basic PLC knowledge.Strong written and verbal skills.Experience with statistical data analysis using JMP and Python.Ability to collaborate in a multi-disciplinary environment within a Next Generation Sequencing (NGS) group.Familiarity with board schematics, BOMs, and test instrumentation (a Plus).Experience using automated inspection instruments.Detail-oriented in data and reports.Strong planning, organizing, and problem-solving skills.Ability to work independently.Able to travel locally and overseas.

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