Spearheaded engineering and transfer of 7 instruments, devices & consumables• Directed design transfer team to achieve FDA 510(k) Clearance & EU release of GEM Hemochron 100 & consumables through documentation, test & fixture design, and packaging design• Lead team to develop hardware, consumables & reagents for VerifyNow update• Facilitated VerifyNow sales expansion into EU by leading team for RoHS upgrade transfer• Supported EU MDR Certificate & FDA 510(k) Clearance for Tenderfoot lancet substantial equivalence by managing team for design review, risk assessment, and biocompatibility & real time aging studies• Oversaw design transfer team for InRhythm consumable EU launchManaged sustaining engineering team for entire Whole Blood Hemostasis product line• Managed sustainment team for GH100 initial launch complaint resolution, including plastic prototype tool upgrade to hard tool redesigns• Advanced GH100 introduction into VA hospital system through bleach sanitation study• Improved on-market product quality by introducing ASTM, ISO & ASME standards• R&D Lead for EU REACH, RoHS, Battery Directive & Corporate Sustainability; achieved compliance for entire WBH product line & packaging• SME for Validation Review, Manufacturing Review & CAPA Boards; assured QMS adherenceFostered high-performing team environment• Formed & directed team of mechanical, biomedical & electrical engineers• Empowered team by developing confidence in their abilities• Improved team capabilities through lab expansion, major technology investments & design of lab-scale processing line for faster reagent developmentCollaborated with executive leadership & across departments• Collaborated with Regulatory, Quality, Ops, Reagent Manufacturing & Development, Finance, Marketing• Worked with VP Regulatory on regulatory issues & customer inquiries• Communicated with VP Operations on solutions for manufacturing issues• Developed annual 5-year resource & capital expenditure budget

Recruited staff for a fast-paced 24/7 aseptic biotechnology manufacturing environment and managed a team of process engineers to resolve technical issues, implement continuous improvement projects, and keep commercial manufacturing operational.