Execution and implementation lead on a 4-year manufacturing transformation plan, delivering $7M+ in annualized cost savings via reduced manufacturing cost and creating space for future manufacturing needs. Resource and manage an operational program team, including dedicated senior project managers and engineers, both on-site and offshore. Responsible for $20M capital expenditure; Collaborate with Finance and Business Unit leaders for capital funding request and approval. Provide capital planning information and monitor capital spending to ensure compliance to targets and spend forecast.Completed full product outsources to CDMOs in Tijuana, Mexico and Penang, Malaysia. Completed full product insources to Becton Dickinson plants in Baltimore, MD and Drachten, Netherlands. Developed statements of work (SOW) with third-party manufacturing (CDMOs), negotiate pricing, and partner with Procurement to manage the supplier relationship.Team up with Business Processes managers and Master Data to ensure ERP (SAP) systems are aligned as product is transferred between locations, as well as warehouse and distribution changes.

Led multiple project teams to outsource high-level assembly (HLA) and subassembly to CDMOs; strategically retaining Final Assembly Integration and Testing in-house at BD. Completed HLA and subassembly outsources to CDMOs in Shanghai, China and Bangkok, Thailand.Owned project plans, Gantt charts, and change controls as the PM; Responsible for transfer plans, quality plan, validation plan, raw material plan, and regulatory strategy and all associated tasks as delegated to the project team SMEs. Validated all quotes from CDMOs during the RFQ phase and made recommendations to Procurement for business award.Coordinated and hosted CDMO representatives on-site in BD plant for product training and multi-week manufacturing floor shadowing. Spearheaded the approach with Trade Compliance, Legal, and Regulatory on assessments of ‘site manufacturer’, ‘significant transformation’, and ‘Made in USA’ claims.

Led monthly assessment and prioritization of plant projects.Owned and resolved CAPAs, dispositioning of non-conforming material and Quality Notification tasks. Initiated change controls defining all project deliverables and ensured all deliverables were achieved. Interfaced regularly with procurement and outside suppliers for prototyping new products, improving current designs, and cost savings. Responsible for the management and development of direct reports.

Launched Class III diagnostic instrument to Ex-US CE marked regions in 2013 and in the US in 2014. Primary point-of-contact with an outside design firm and held firm accountable for $1,000,000 budget and instrument design for manufacturability deliverables.Accountable for all aspects of design transfer for instrument and automated reagent manufacturing, including vial filling, capping, and labeling. Partnered with label vendor to develop a new vial label containing 2D barcoded information and 2-ply construction that was fully compatible on current manufacturing labeling line.

Design engineer responsible for the development DERMABOND ADVANCED™ Topical Skin Adhesive. The device consists of a polypropylene base, a compressible silicone bulb, a crushable glass ampoule containing the surgical sealant, and porous filter infused with a chemical initiator. Led verification activities for the delivery device for ETHICON™ OMNEX™ Surgical Sealant, a Class III product and the first cyanoacrylate chemistry approved in the US for use inside the body for vascular repair. Responsible for proof of concept of PRINEO™ Skin Closure System, comprised of topical skin adhesive and a polyester textile mesh substrate.Served as Product Development engineer on various other projects to assess potential tissue sealant applications such as gastrointestinal, pulmonary, rotator cuff, and dural membrane indications.Defined, wrote, implemented, and maintained product specifications, CAD models, drawings, design verification / validations, and inspection criteria. Participated in multiple market research studies and observed many human surgeries, interacting with key opinion leaders and surgeons to gather Voice-of-Customer data. Interpreted VoC data into product requirements for devices such as intuitiveness/ergonomics, aesthetics, activation force, and sealant volume.Hands-on in multiple in-vivo animal studies.