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Over 20 years experience in directing manufacturing operations of Medical Device production, transitioning innovative technologies from the early Startup phase to full Manufacturing. Experienced in developing, validating and implementing, Manufacturing processes for emerging Medical Device technologies. With a proven track record that includes being an integral part of two consecutive, extremely successful, Medical Device start-up ventures, from pre-production prototypes, through multiple production ramp-ups, and on to becoming the industry leaders in their fields.Specialties: Medical Device, Manufacturing/Operations Management, Contract Manufacturing, Training, Product Transition to Manufacturing, Establishment of Manufacturing Processes, Process Development, FDA and Regulatory Audits, Leadership, Continuous Process Improvement, Six Sigma, Scaling Manufacturing Capabilities, Lean Manufacturing, Project Management, Reliability, Test Development, Management, Documentation Procedure Writing, Product Testing, Automation Testing, Validation and Verification, LabVIEW, C/C++, Objective C Programming, Data Acquisition, Business Process Improvement.
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Director Of EngineeringPerfect Lens LlcIrvine, Ca, Us -
Director Of Manufacturing OperationsPerfect Lens Llc Jan 2018 - PresentIrvine, Ca -
Director Of Manufacturing OperationsIntegrated Endoscopy Oct 2016 - Dec 2017Rancho Santa Margarita, Ca• Directed all Manufacturing Operations including procurement, manufacturing engineering, assembly, testing, packaging, and warehouse. • Established production lead times, staffing requirements, and related cost figures.• Planed work force utilization, space requirements and workflow.• Re-designed layout of manufacturing workspace and equipment for maximum efficiency and Lean product flow.• Liaison for key component / subassembly suppliers and contract manufacturers. -
Manager Of Manufacturing OperationsAlcon Lensx Aug 2010 - Oct 2016Aliso Viejo, Ca• Maintained metrics tracking production performance, product quality and production safety.• Developed and maintained monthly production schedule and daily build plan.• Responsible for managing the manufacturing of Spare Parts.• Introduced Cost Cutting measures through implementation of lean six sigma and 5S manufacturing principles.• Developed annual budget for Capital Equipment, Expenses for the LenSx product line.• Forecasted resource management, maintaining monthly labor utilization targets.• Alcon Certified Lean Six Sigma Green Belt. – LenSx was sold to Alcon for $744 million in 2010. -
Sr. Manufacturing EngineerLensx Lasers Oct 2008 - Aug 2010Aliso Viejo, CaThe LenSx laser was the first femtosecond laser approved by the FDA for use in cataract surgery, bringing image-guided computer precision to refractive cataract surgeons.Joined at the initial startup (2008)• Successfully transferred New Product Technology from R&D to Manufacturing• Established and Developed the Manufacturing department from the early startup phase through preproduction and on to full Production. -
Manager Systems TestIntralase - Advanced Medical Optics Jun 2001 - Sep 2008Irvine, CaThe IntraLase FS laser was the first FDA approved technology for an all-laser, blade-free LASIK procedure, replacing the hand-held Microkeratome blade historically used in creating LASIK corneal flaps with a computer-guided, ultra-fast femtosecond laser. Joined in the early startup phase (2001)• Developed and expanded the Systems Test department from the first pilot units on to a full production builds.• Met or exceeded Production Goals each quarter, for 25 consecutive quarters, despite the numerous challenges associated with new product launches and ever increasing product demand.• Managed the daily activities of a team of 10 Systems Test Engineers to produce product on time, and cost effectively.• Maintained, and modified Test Equipment, New Fixtures, and Calibrating Tools as need, on the Production floor.• Managed RMA activities through the Systems Test group for two years until an official RMA department could be established. • Developed and oversaw Manufacturing review process of Device History Records to verify accordance with SOP and FDA requirements.• Collaborated with R&D concerning necessary Test Equipment and LabVIEW code modifications driven by upcoming product design changes.• Collaborated with management, engineering, and other staff regarding Systems Test capabilities, production schedules, and other considerations to facilitate production processes.- IntraLase had a successful IPO in 2005 and was sold to Advanced Medical Optics for $808 million in 2007. -
Test Development EngineerCymer Feb 1997 - May 2001• Developed and introduced Standardized Mobile Testing to replace existing dispersed and varying test equipment, thereby insuring reproducibility in all test bays and allowing scalability of Manufacturing’s test capacity to over 30 systems simultaneously. *Received Company Recognition Award for Innovation*• Developed a LabVIEW app to text message Test Engineers on the progress of their Laser System in automated burn-In, which increased productivity by freeing them to begin work on a second system in parallel.• Developed Test equipment and LabVIEW code for over 30 test bays at Cymer’s production floor in Rancho Bernardo, CA.• Developed and Installed Test equipment and LabVIEW code for 10 test bays at Cymer’s international facility, via annual trips to, Sieko Instruments in Japan. -
Electronics EngineerOmnichrome Oct 1989 - Feb 1997• Introduced Data Acquisition hardware and LabVIEW software into the manufacturing process. • Increased productivity by Automating the Laser Burn-in process, freeing up technicians for other work. • Managed a team of assemblers, technicians, and engineers, on a Microprocessor Embedded Laser Power Supply development project.• Lead Engineer on a low cost Forensic Light Source project.• Designed a Remote Control product for Argon Laser line. • Lead Electrical Engineer for the Helium Cadmium Laser Line. • Lead LabVIEW Programmer
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Frequently Asked Questions about Don Boyer
What company does Don Boyer work for?
Don Boyer works for Perfect Lens Llc
What is Don Boyer's role at the current company?
Don Boyer's current role is Director of Engineering.
What is Don Boyer's email address?
Don Boyer's email address is do****@****ope.com
What are some of Don Boyer's interests?
Don Boyer has interest in Mobile, Clean Technology, Environment, Health Care, Science And Technology, Consumer Internet, Enterprise Software, Human Rights, Health.
What skills is Don Boyer known for?
Don Boyer has skills like Medical Devices, Manufacturing, Testing, Electronics, Lean Manufacturing, Validation, Fda, Product Development, Labview, Project Management, Design Control, Test Equipment.
Who are Don Boyer's colleagues?
Don Boyer's colleagues are Steven Smathers, Brian Lee, Ruth Sahler, Josef Bille.
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