Principal Process Engineer

United States of America, California, Santa Clara

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ESSENTIAL DUTIES

  • Establish an integrated manufacturing process throughout an international supply chain including development of automated in-process and incoming dimensional and mechanical characterization, baking and cleaning establishment, molding parameter sweeps, process recipe optimization for thickness and desired material properties, shipping between vendors and establishment of incoming and outgoing procedures at vendors

  • Collaborate and guide suppliers to ensure components are made to minimize cross- contamination to enable a pristine sequencing surface

  • Executing failure analysis investigations, risk impact assessment and root cause investigations

  • Generating 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

  • Visiting external suppliers regularly to select, transfer, bring-up and troubleshoot processes

  • Responsible for collaborating/guiding fixture developers to design and implement new or improved MFG tools/fixtures into supplier manufacturing lines.  

  • Interface with design engineering and Operations to decide cavitation and other scaleability requirements for production tooling, qualification plan, execution of plan and report

  • Develop/iterate incoming/outgoing inspection documentation, procedures, specification and implement at suppliers

  • Drive continuous improvement plan (CIP), design for manufacturability (DFM) projects for quality improvement and cost reduction between suppliers and internal teams

  • Creation, monitoring and mitigation of SPC tracking, yield pareto charts and other in-line metrics

  • Support field and internal investigations

  • Craft process recipe matrices in support of yield, reliability, efficiency and quality improvements

 
EDUCATION, EXPERIENCE and REQUIREMENTS:

  • B.S. in Engineering, Mechanical, Electrical, Chemical, or related field with minimum 7 years of experience 

  • Experience with multiple transfers of new molding designs through a fully established commercial line is a must

  • Strong understanding of medical device manufacturing requirements is critical

  • Familiar with fluid and pneumatics circuits from schematics readings, P&ID’s troubleshooting, components assembly and testing including microcontroller and basic PLC knowledge.

  • Strong vendor communication capability both domestically and international

  • Prefer experience with statistical data analysis using JMP, python or R

  • Willingness to collaborate in a multi-disciplinary environment within a Next Generation Sequencing (NGS) group

  • Interest and curiosity in understanding and analyzing sequencing data as the product to guide the best process development decisions

  • Prefer familiarity with board schematics, BOMs and test instrumentations

  • Experience using automated inspection instruments

  • Good written and verbal communication and presentation skills.

  • Strong attention to detail, accuracy and completeness of data, reports, records, etc.

  • Creative problem solving skills.

  • Good organizational and planning skills.

  • Ability to work independently and with others as a team.

  • Able to travel local and overseas multiple times a year

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.