Michael Harris

Define and execute validations of complex capital equipment and manufacturing infrastructure including lyophilizers, terminal sterilizers, autoclaves, asceptic processing areas, HVAC, CIP and SIP systems.

▪ Process Development lead of two projects, determining direction for the teams and providing mentorship. ▪ Designed and analyzed DOE’s, Utilized Root Cause Analysis tools, and presented technical reviews to stakeholders. ▪ Authored Master Validation Plans (MVP’s), and operator work instructions for two manufacturing lines including the following processes: polymer laser bonding, hot die bonding, swaging, UV adhesive bonding, epoxy bonding and cure, leak test, deburring, ultrasonic cleaning, ultrasonic welding, electrical test, conformal coating, and packaging. ▪ Procured fixtures, and released fixture drawings and custom epoxy cure station drawings for an entire catheter line. ▪ Developed tensile and precision dimensional test methods; also completed Test Method Validations (TMV’s). ▪ Completed Kaizan events evaluating potential Lean Manufacturing improvements. ▪ Led a CAPA to completion resolving quality system gaps in an acquired business.

▪ Recruited and onboarded process development engineers to strengthen the team’s capabilities. ▪ Directed, coached, and oversaw the team in developing innovative products, including a thrombectomy catheter, venous self-expanding stent and delivery system, thermal ablation catheter, and liquid embolic delivery catheter. ▪ Conducted thorough employee performance reviews and justified promotions based on achievements. ▪ Drove project charters, and manufacturing site selection. ▪ Led a CAPA from investigation through verification of effectiveness. ▪ Collaborated with equipment suppliers to design and build customized reflow and press process equipment that met design for cell operating system initiatives.

▪ Process development lead coordinating and providing work direction for other PD engineers, authoring the MVP, and Process Performance Qualification (PPQ), and driving timely approvals of all documents required for validation and product launch. ▪ Engineered innovative processes to mitigate handling damage. Identified Poka-Yoke opportunities and executed essential fixture modifications. ▪ Managed Engineering resources across two new product development projects and commercial products while spearheading the installation of a balloon catheter production line. ▪ Project Manager New Product Development: Collaborated with another site to develop and launch a next-generation RF generator that safeguarded a $200M annual revenue stream. Our team earned a cross-business collaboration award. ▪ Project Manager Commercialization Phase on two projects: Collaborated with contract manufacturer to report out quality metrics and utilized root cause analysis tools to successfully resolve issues. Collaborated with internal manufacturing site to successfully close required actions of the phase. Completed Impact Assessment for a patient card issue that allowed the clinical trial to continue. Completed phase for both projects on time and within budget.

▪ Completed DOE’s, IQ, OQ, and PQ for balloon pleating and folding processes to support the launch of an internally developed first generation balloon catheter. ▪ Contributed to the development and successful launch of a first-generation support catheter by evaluating and developing RF tipping and polymer reflow processes. ▪ Guided a team in conducting comprehensive DOE’s identifying critical design adjustments to resolve key customer complaints and enhance product performance of a balloon catheter. ▪ Analyzed product complaints, uncovered root causes using failure mapping and statistical tools, and collaborated with design engineers to implement and validate process and design improvements on a stent delivery system. ▪ Led a CAPA to successfully resolve a quality issue on a subassembly with an over molding supplier.

Process Development of Polymer Laser Bonding

Process Development Extrusion and Balloon Forming

Process Development Balloon Forming

Process Development Balloon Forming

BS in Manufacturing Engineering