Business Development Project Management
Resume:
Daniel J. Summers
ad5u8g@r.postjobfree.com
Santa Clara, CA
SUMMARY
• Leadership, Introspective, Sales and Business Development, Execution and Delivery, Technical Expertise, Program / Project Management
• Experienced leader, specializing in medical device development, operations, and program management. Recognized for driving 12 ophthalmic system programs, including groundbreaking LASIK technologies, from concept to billion-dollar revenue. Proficient in clinical & regulatory compliance (FDA, ISO, ANSI), technology migration, and mergers/acquisitions integration. Expertise in demand flow technology and extreme growth scaling. Expert at leading cross-functional teams, risk management analysis, successful product launches, and continuous improvement programs post-launch. Seasoned in both development and operations roles, positioned to best fulfill corporate goals with short timeframes for high-quality outcomes.
• A collaborative, highly inspirational executive who has shown value by:
• Redesigned the Wavescan VFA system, cutting service costs by an impressive 80%, enhancing product performance, and minimizing field failures.
• Implemented data migration projects into IFS MRP from PLM and MRP systems of acquired technologies and over a 20 year period, from SAP to IFS, from excel spreadsheet-based inventory system into IFS and Agile PLM system, and from Oracle’s Agile into IFS systems. Added all Kanban sizes to accommodate Demand Driven MRP to include recursive process loops within the product line.
• Led the technology transfer of Questek, 2010 Perfect Vision GmbH, and IntraLase, streamlining operations, and achieving facility consolidation within two years of each acquisition, exemplifying expertise in integration and cost-effective solutions.
• Successfully mitigated project risks by designing a watchdog circuit, ensuring safety during clinical trials, and enabling the completion of clinical trials within the set timeline.
• Implemented Demand Flow Technology to optimize manufacturing operations, resulting in a 30% reduction in parts costs, significantly improving supply chain efficiency.
• Swiftly resolved High-Voltage Power Supply (HVPS) failures, restoring production within two weeks, and saving $350,000 per week in lost revenue.
AREAS OF EXPERTISE
• Medical Device Research, Development Leadership, Operations Management, Program Management, Regulatory Compliance
(FDA, ISO, ANSI), Technology, Team Motivation, Migration, Mergers and Acquisitions Integration, Demand Flow Technology Manufacturing, COGS, DFM/DFA/DFT/DFS, Continuous Improvement, Contract Manufacturing/ OEM Management, Budget Management, Commercialization, Team Motivation, Project Leadership, P&L Management, ISO Standards (ISO 13485, ISO 9001), 21 CFR Part 820 Compliance, CMC, GMP, System Design, Risk Assessment (ISO 14971), GAP Assessments, Program/Project derisking, CE and FDA Approvals, PLM and MRP Implementation, Strategic Planning, Product Design and Development, Feasibility and Laboratory Testing, Biocompatibility testing and adherence, Disposable products compliance and manufacturing, Verification and Validation, IQ/OQ/PQ, System Design (IEC60601), Labels creation, Project Management, Patent Issued US 9,427,357 B2
INDUSTRY EXPERIENCE
• Research & Development, Custom Software & IT Services, Architecture, Engineering & Design, Medical Laboratories & Imaging Centers, Medical & Surgical Hospitals, Computer Equipment & Peripherals, Medical Devices & Equipment, Electronics, Enterprise Resource Planning (ERP) Software, Healthcare Software, Reagent and drug development & approval management, Clinical Operations Leader.
LANGUAGES & FRAMEWORKS
• Java, Python, C, C+, Virtual Basic, Pascal, Fortran, Modula II METHODOLOGIES
• CAPA, SMART Goal setting, AGILE, LEAN Six Sigma, Demand Flow, TPS, DMAIC troubleshooting processes, Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Testability (DFT), Design for Serviceability (DFS), Design for Usability (DFU)
TECHNOLOGY
• Tableau, Palasm, Cupl, VHDL, Allegro, Altium, OrCad, Schema, Pads Logic, & Tango PCB, MS Project, PowerPoint, Excel, Access, Word, SolidWorks, and Autodesk AutoCAD
EXPERIENCE
Eyelight Innovations Inc. 2018 – 2023
VP Program Management/Laser Technology Expert
• Developed requirements for a novel MIGS Guided ELT system, ensured compliance with regulations, established corporate infrastructure, software design, and facilitated regulatory approvals.
• Key Skills: Program Management, Regulatory Compliance, Technology Migration, Demand Flow Manufacturing
• Launched Eyelight Innovations Inc. as a new startup, overseeing the entire formation process and bylaws creation.
• Successfully managed a budget exceeding $15MM, demonstrating strong financial acumen.
• Led the development efforts for a cutting-edge MIGS Guided ELT system, from concept to compliance with 21 CFR part 820 and ISO 13485.
• Led the disposable development for the GELT system ensuring biocompatibility and sterility compliance of the finished SKU.
• Created corporate infrastructure and procedures to adhere to ISO 13485 & 9001, facilitating CE and ETLc approval.
• Implemented PLM, MRP (ERP), QMS, and other cloud-based systems for seamless operations compliance.
• Devised a comprehensive 15-year Proforma outlining all costs and projections, showcasing a strong strategic outlook. ClerioVision Inc. 2015 – 2020
Director of Development, Compliance, and Operations
• Led technology transfer from U of R Optics labs to ClerioVision for LIRIC systems, ensuring safety compliance. Conducted clinical trials in San Salvador Eye Clinic, achieving successful short-term refractive results.
• Key Skills: Development, Compliance, Program Management, Quality Assurance
• Managed a team responsible for the development of high-speed laser scanning systems.
• Managed the team responsible for the disposable patient interface design and release including compliance approvals.
• Oversaw a budget exceeding $12MM, demonstrating strong financial management skills.
• Drove system development from conception to release, ensuring compliance with ISO standards, including 13485, 21 CFR part 820, 62304 (S/W), and 14971 (risk).
• Led successful clinical trials of the LIRIC system in Central America, completing 36 eye trials within 2 years of concept.. Abbot Medical Optics 2008 – 2015
Director of Operations Engineering (Manufacturing)/Program Management
• Oversaw product lifecycle management across multiple product lines, ensuring quality and compliance. Managed new product launches and facilitated design transfers, achieving Six Sigma Black Belt certification.
• Key Skills: Operations Engineering, Program Management, Compliance, Budget Management
• Quickly resolved HVPS failures, saving $350,000 per week, and minimizing two-week downtime, resulting in total savings of
$700,000.
• Strategically lowered certain risks of project, reducing overall risk, and ensuring a low-risk project.
• Assisted contract manufacturers with manufacturing setups for medical disposable parts (Patient Interfaces).
• Successfully retrofitted Demand Flow Technology into production lines, saving 30% ($3,000,000) on parts costs, and optimizing the supply chain.
• IEC60601 compliance approvals for all Abbott Laser Products.
• Risk assessment and Hazard Analysis for all Abbott Medical Products. Advanced Medical Optics 2005 – 2008
Senior Manager Operations Engineering (Manufacturing)
• Managed Operations Engineering for global AMO medical equipment. Led cross-functional programs, enhancing manufacturing processes, fixtures, and implementing lean practices for efficiency and quality improvements.
• Key Skills: Operations Engineering, Lean Manufacturing, Process Improvement
• Implemented a redesign of the ASTIG module, reducing field failures by over 94% and significantly improving the performance of the WaveScan VFA system, resulting in an 80% reduction in service costs.
• Led the absorption of IntraLase technology into the corporate headquarters, completing FDA-required V&V within two years and consolidating production, resulting in manufacturing FS60 and iFS in the Milpitas facility. Visx Inc. 1992 – 2005
Manager Operations Engineering
• Managed manufacturing engineering for Ophthalmic Laser and Aberrometer Systems. Streamlined production with pull systems, tech
• transfer, optimized cycle times, enhanced manufacturing methods with developed processes, and ensured compliance.
• Key Skills: Operations Engineering, Lean Manufacturing, Production Line Balancing
• Traveled to Germany, gathered technical information, imported it into our PLM system, and released WS1 within 2 years of the PerfectVision acquisition, making the WaveScan System available for sale.
• Successfully integrated Questek's technology into our STAR system, leading to the STAR system's production release for commercial sale.
• Sole Signature authority for IEC60601 listing reports for all VISX products.
• Clinical (PMA) support for the STAR system
Questek 1986 – 1992
R&D Electronic Design Engineer
• ISA bus 80X86 based I/O and peripheral PCBs used to control and monitor laser systems
• Excimer laser head discharge and pulse forming circuitry
• 6.0KW, IGBT based, 32KV HVPS used to charge a 96 ηFD main storage capacitor banks
• High voltage feedback, digitizing, and fiber optic conversion data modules (Manchester encoded)
• Extensive PLD and FPGA design experience using Palasm and Cupl.
• Schematic capture, net list, and BOM generating using Altium, OrCad, Schema, Pads Logic, & Tango
• Design fiber optic system serial communications (Manchester encoded) links for all internal laser modules using HP plastic core fiber interconnecting all modules.
Key Skills: Pulsed Power design and development for medical devices, mixed signal circuit design,
■ Designed the pulsed power Module, HVPS, and control system for the new Excimer Laser series 3000 system which I then migrated into the VISX Star system for the first LASIK (PRK) use. AAO and ASCRS current Laser Safety Team Member
EDUCATION
Bachelor of Science (Equivalency), Engineering Technology Cogswell Polytechnical College: Exceeds degree qualifications based upon a combination of college courses and progressive roles across the medical device industry
DEVELOPMENT CERTIFICATION
• Training & Development: High Power Work Teams, Toyota Production Systems, AMA Management Courses, Actions for Results Project Management Courses, Advanced Project Management Courses, McKinsey & Co training
• Certifications: Six Sigma Black Belt, Six Sigma DOE
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