Weley Lin Email & Phone Number

Sunnyvale, Ca, Us

Sunnyvale, Ca, Us

Luxembourg, Luxembourg, Lu

- Portfolio Strategy and Operations • Led multiple cross-functional projects spanning diagnostics instruments, consumables, and pharmaceuticals• Planned, documented, and executed all phases of the project lifecycle, including scope, requirements, schedule, budget, and dependency management• Conducted risk/opportunity assessments with teams and explore options for proactive mitigation• Support the preparation of stage-gate documentation, progress updates, change requests, governance presentations, and other communications

San Diego, California, Us

- Project Management • Managed project deliverables such as drawings, purchase specifications, process flow diagrams, change requests using QMS, BOMs, and other documentation in the Design History File (DHF) for various projects from project initiation to verification and validation, ensuring compliance with ISO13485• Led internal design reviews and phase exit reviews with R&D, Instrument, Operations, Quality, Regulatory, and other departments to ensure alignment on project deliverables• Primary point of contact with manufacturers to ensure smooth collaboration and timely delivery of custom molded components• Product specification owner of multiple test cartridges, from kit-level to ship-level. Ensured that deliverables were prioritized appropriately per the organization's strategic objectives• Coordinated the launch of SolidWorks 2021 across the company to optimize efficiency and collaboration- Product Development• Led engineering studies to qualify alternative components for the test cartridge to reduce overall cost of assembly. Coordinated studies with multiple departments and external vendors.• Conducted process characterization and optimization testing for a vision system on the high-volume automation line• Responsible for setup and documentation (EMF, WI, LHR, pFMEA) of multiple machines on the SMT (PCBA) Production Line• Managed design control activities, including the creation of design inputs, design outputs, verification and validation protocols, and design history file documentation • Coordinated with cross-functional teams including R&D, Quality, Operations, Regulatory, and Marketing to ensure timely completion of project milestones

San Diego, Ca, Us

Disposable for use in Fluorescent Immunoassay Analysis (Sofia 2)• Designed and developed injection molded prototypes to be used across different assays• Collaborated with Chemistry R&D, Quality, and external suppliers to design and implement test protocols to determine the necessary fill volume and torque specification of the reagent vials Instrument for Fluorescent Immunoassay Analysis (Sofia 2)• Developed, implemented and documented test protocols to determine the optimal test line search range for the instrument. Stack up analysis helped reduce the occurrence of invalid tests by ~2% and increased line sensitivity by ~5%• Verified that new parameters met the performance criteria for initiating design transfer by reanalyzing test data in Python, analyzing results on Image-J, and verifying the process capability on StatgraphicDisposable microfluidic cartridge for PCR Analysis• Lead root cause analysis of undesirable bubbles by mapping and analyzing the workflow in the extraction and PCR microfluidic cartridges• Developed and executed functional tests on the extraction and PCR microfluidic cartridges and used the results to propose design features and improvements for performance and manufacturability• Designed test fixtures and prototypes to help troubleshoot issues with the cartridge using feedback from Chemistry R&D, Electrical Engineers, and Operations. Prototypes were created using Solidworks, 3D printing, machining, laser cutting, adhesives, and injection molding• Designed and ordered heat weld plates for the sensitive microfluidic channels

Charlotte, Nc, Us

• Analyzed the shear strength of various core designs using Abaqus to assist in design down-selection• Programmed a Matlab script to consolidate acoustic data of core designs into a database

San Diego, Ca, Us

• Reduced assembly time by 33% for the Blood Separation Pad Holder Device that was designed to filter plasma from blood samples • Collaborated with Chemistry R&D to test multiple prototypes created using Solidworks and 3D printing• Improved design manufacturability to support high volume production

San Diego, Ca, Us

• Performed plan reviews of engineering drawings and verified that they aligned with city standards • Assisted in the revisions of the Design Guidelines and Standards documents• Analyzed pump station efficiency and prepared cost-benefit analysis for an additional turbine pump