Joe Crosby ~ Senior Design Quality Engineer Email & Phone Number

Cambridge, Cambridgeshire, Gb

Austin, Texas, Us

Hired by Flex to bolster the Quality Assurance Group’s ability to incorporate engineering design accuracy into the Quality verification process by contributing engineering exactness into Design Control deliverables. Worked on complex technical problems, utilizing quality engineering methods to provide innovative solutions. Lead quality product improvement initiatives. Provided QA support for multiple new product development teams from late stage feasibility through transfer into commercial and/or clinical manufacturing operations. Worked closely with research and development organization to ensure potential product issues were identified and addressed in the design. Ensured compliance with corporate and regulatory body requirements for medical devices and combination products. Guided cross-functional test planning to facilitate key stakeholder engagement. Developed and initiated sampling procedures, statistical process control methods, new test tools and protocols, ensuring that test objectives were effectively incorporated. Applied design for reliability (DFR) and design for test (DFT) concepts (DFMEA, FTA) during the product development process to ensure that designs were intrinsically reliable. Maintained DHF to ensure content integrity, completeness, and regulatory/standards compliance; collaboratively communicating & resolving gaps. Communicated with program management and customer regarding quality assurance activities. Participated in customer and internal audits. Monitored CTQ parameters and specifications during product development lifecycles. Communicated with customers on quality issues for continuous improvement, perform internal/external corrective and preventive actions as required. Held Change Control Board meetings and ensured change impact analysis is performed and engineering change requests are tracked and implemented.(February 2019 – April 2020 due to Flex Reduction in Force)

Zurich, Ch

Key Assignments: Lead Design Quality Assurance / Remediation Engineer. Zimmer-Biomet, Warsaw, IN Leader of FDA mandated project to add Unique Device Identifiers (UDI) to over 2,600 Legacy Biomet Class II & III surgical instruments and implants. Responsible for directing and training team of seven on-site and offshore resources, developing and refining scope with internal business units and tracking change progress. I was also responsible for identifying all tasks required to complete project assignments according to Design Control procedures, prepare impact analysis outlining estimated manpower requirements and development costs, recommending project budget and schedule to complete deliverables to meet the project deadline. All work was done using Unigraphics NX and Siemens Teamcenter. Upon completion of the UDI project, the team actively worked to create and prep a similar process for EUMDR.Senior Product Development Engineer. Integra LifeSciences, Austin, TX SME on multiple cross-functional teams tasked with the design remediation for new Integra product lines (13 trays of Class III orthopedic implants and instruments) gained through acquisition. My responsibilities included: gap analysis of Design History Files, completing action items driven from gap analysis, conducting mechanical testing, updating drawings and engineering documentation using Solidworks and Creo 3 (Pro/Engineer), update DHF and technical files to support regulatory submissions, conducting tolerance stack analysis, writing inspection procedures, creating ECOs and BOMs using Agile PLM system, and working with vendors and other Integra sites to bring all products on line.

Responsible for all ClearCube Product Design / Test / Regulatory Certification / Production Release and sustaining engineering. Products designed for rugged environment included; server class blades and chassis, graphic and networking components for remote computing, zero and thin client devices. Manager of the engineering and testing lab and lab staff. Trained lab personnel in cGLP. Designed and wrote test protocols, technical memos and documentation to support testing new and sustaining product development. Developed and implemented metrics to conduct component inspection, failure analysis and mechanical testing. Prepared and monitored expense budgets and input to relevant capital appropriation requests. Provided direction for interpretation and application of company SOP’s, safety policies and procedures.

Hanover, Maryland, Us

Key Assignments:Project Manager. Kinetic Concepts, Inc. (KCI) San Antonio, TXSustaining project manager for cross-functional core team performing Value Analysis/Value Engineering (VAVE) in an FDA regulated environment. My team successfully created over $2 million in annual savings by optimizing design and existing infrastructure for high volume medical disposables. Completed two invention disclosure submittals to the KCI patent board.Senior Product Development Engineer. Illumitex Austin, TXDesigned mechanical, thermal and optical packaging components for device level LED packages. Using design analysis, balanced thermal, optical, and electrical performance against raw material, assembly and test costs to optimize the design. Created high precision, molded lens systems with tolerances of ±20 microns utilizing Solidworks with input from ZeMax.Design Remediation Engineer. DJO Surgical Austin, TXRemediation design of complex orthopedic knee and shoulder implants using SolidWorks. Performed tolerance analysis studies, ECO’s, CAPA’s, and the re-design of shoulder implant products.