Norman Labrecque Email & Phone Number

Monroe, Connecticut, United States

• Managed a project that delivered an innovative new endoscope, in material, from production tooling, featuring:‣ Endoscope system, reusable plus disposable, targeted as Class II medical device / 510k‣ Mechanical design through Solidworks and rapid prototypes created solely in-house‣ Video streaming by custom circuit board executing video acquisition, format conversion, real-time transmission to user output - plus other functional subsystems and features‣ Circuit board – managed contracts for hardware design, integration, firmware and software programming, device authentication, cyber/HIPAA security; fabrication and assembly‣ IEC 60601, 60529 IPx8, ISO 10993, 14971, 8600 compliant• Procured tooling and components; provided design and validation engineering support‣ Injection molds and fully validated molding services for fourteen components ‣ micro-molds, elastomer overmold, PSU, ABS, PC, PBT, LCP, TPV materials‣ Extrusion dies and services‣ Laser processing of components – cutting, welding, marking‣ Circuit board designed and programmed to SOW; fabricated and populated• Designed and fabricated laboratory test systems, executed and analyzed laboratory tests.• Supported successful manufacturing scale-up transfer to OUS manufacturing site, sample builds under protocols• Contributed to the success of a VOC/formative three-physician cadaver lab through active support and solicitation for user feedback• Developed/maintained project schedule; capital, expense budgets, costs of goods for reusable & disposable assemblies. NPD final approver for all DHF documents

Fairfield County, Connecticut, United States

• Led successful in-house design, build and deployment of flexible semi-automatic laser welding production system with quick changeover and flexibility for rapid process development. This project integrated laser weld heads, six-axis robotic arms, servo workpiece positioning – FDA CDRH Class-I, ISO 13489 Safety Category 4, GMP compliance confirmed by successful third-party audits• Led successful development and launch of company’s first OEM product line consisting of a twelve-member spine needle family (Class II 510k, CE). Devices penetrate vertebrae while integrated with neuro-monitoring and 3D live imaging guidance during minimally invasive spine surgery• Managed user inputs, design inputs and outputs; finite element analyses and tolerance stackup analyses supporting medical device design history files• Performed product design and DFM of components by injection molding, machining, wire edm, powder coat insulation; assemblies snap-fit, bayonet, laser welding, soldering, heat staking, uv adhesive bonding• Collaborated with customers and transformed product concepts into robust manufacturable designs• Mentored junior engineers, assigned and supervised activities in design, testing, and tech transfer• Delivered DFM, rapid prototype builds and testing of new medical devices including OEM Pedicle Access Needles; OEM Ligament Tensioner (Class I 510k), Pancreas and Breast Biopsy; Cryo Ablator

• Managed projects to $1.2 million that delivered new high-speed production lines; automation; new processing and piping systems; support utilities; and GMP manufacturing spaces in an FDA regulated environment• Managed project engineers, tool & die shop, and production technical team to continually improve processes and meet daily tooling, changeover, and repair demands• Improved design and managed operation and expansions of USP Purified Water system achieving 99.8% scheduled uptime in supplying critical raw ingredient for annual $360 million annual product sales• Redesigned chillwater distribution system saving $84,000 and a week of facility outage• Developed condition and response specifications for PLC based control systems and used ladder logic to qualify and troubleshoot systems. Spearheaded automated monitoring and control system that streamlined regulatory data collection and troubleshooting• Built computerized flow models to achieve capital cost reductions; provide multiple scenario analyses; and to support operations and future upgrades of distribution systems