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