SUMMARY
Anadaptable and driven achiever with executive level medical device Operations and Engineering management experience, reliant on adiverse engineering background, hands on approach, and relationship management expertise. A leader in implementing streamlined ISO 13485 and cGMPQuality Management Systems that has successfully directed clinical product production,product transfer to manufacturing, and the commercial production of Class I, II and III medical devices.
ACHIEVEMENTS
- Commercialized (transferred to production) four Class II orthopedic product lines.
- ImplementedfocusedERP systems at zero cost which automated Quality and business processes enabling ISO 13485 certification, increased personnel effectiveness and provided real time reporting for two startups.
- Architected virtual infrastructure to produce GLP compliant prototype and clinical Class I medical devices.
- Reorganized and unified a manufacturing department for Class III medical device. Clarified priorities to drive completion of assembly process development with LEAN objectives which eliminated build to stock subassembliesand enabled the production of for human use implantable product.
- Transformed an unstable contract manufacturing group producing Class I, II, III and combination devices into profitable customer driven organization by streamlining processes and implementing single point of contact project management. Salvaged $1M clinical combination device project. Increased revenue (estimated doubled sales over two years) by developing new customer relationships.
- Partnered with key supplier to solve issues with critical component and develop advantageous turnkey pricing model. On time shipments increased from 40% to 80% and accepted lots increased from 25% to 70% over four quarters. Convinced the supplier to provide proprietary component safety stock to mitigate risk.
EXPERIENCE
Director of OperationsNextremity Solutions, Red Bank NJNov 2011 – Feb 2016
Managed the operations of anISO 13485 certified Class II orthopedic device developer, manufacturer, and reselleras the Head of Quality with control and oversight of supply chain/manufacturing, Manufacturing Engineering, customer service, distribution, and the Quality Management System.Implemented effective systems and infrastructure, and cost of goods reduction plans to enable growth and maximize long term profitability. Direct reports were Senior Quality Manager and Customer Service Manager.
- Head of Quality/Management Representative on file with FDA, ISO Registrar and European notified body.
- Instrumental in driving the resolution of significant Quality Assurance issues relating to both device design and manufacturing. Partnered with suppliers to solve complicated inspection issues, and refine manufacturing approach.
- Implemented and overhauled Quality Management System to ensure ISO 13485 certification and CE Mark renewal. Economized and automated most processes to enable increased accuracy and revenuepotential without increasing staff.
- Built and implemented custom ERP intranet system to automate Quality record generation. Included procurement and inventory control, order entry, distribution and returns, complaints, and sales reporting. Developed automated email reporting for executive staff and sales partners. Implemented web portal for channel partners.
- Planed and produce sterile products,and manageddistribution services. Enabled$2.3M sales for 2012, $3M for 2013.
- Managed production and packaging sourcing, transfer to manufacturing, and commercial release for four product lines.Oversight included entire supply chain, and all supplier relationships and agreements.
- Established outsourced warehousing and distribution and implemented without any service interruptions. UtilizedERP system providing real time reporting and eliminating need for complicated data/systems integration.
- Managed outsourcing of all IT infrastructure to the cloud, including email, web and application servers.
- Consolidated NJ offices to single location, increasing square footage with more useable office and inventory storage space for less expense than multiple locations.
Director of ManufacturingInnerPulse, Durham NCNov 2007 – Jan 2011
Responsible for $1.5M annual budget for Class III intravenous implantable defibrillator assembly process development and validation, including production of GLP compliant human use product with oversight of associated catheter tools, production equipment (IQ/OQ/PQ and maintenance), materials, QA systems implementation and training, clean room operations, and sterilization (EO). Direct reports were Sr. Manufacturing/Mechanical Engineers (3) (PHD and Masters), Materials Manager, Technician and assembler.
- Restructured department objectives and budget to focus on human safety study requirements. Adopted as Strategic direction for company because establishing commercial production capabilities toward selling the technology was too broad a focus to prove product platform viable.
- Streamlined device assembly process by restructuring to remove build to stock subassemblies halving assembly time and device history records. Established simplified process development projects and monitoring, including IQ/OQ/PQ and process validation plan. Assembly process included micro soldering, UV adhesive bonding, laser welding of titanium, automated testing, and elastomeric dip coating, packaging and sterilization. Generated DFM requirements.
- Architected and implemented zero cost systems in eight months integrated with Agile Advantage PLM to automate Production, Materials, and QA management processes enabling ISO 13485 certification and real-time reporting.
- Coordinated and participated in third party Six Sigma Green Belt and process validation training which included applying DOE and Gauge R&R to resolve existing adhesive bonding and micro connector pin location issues.
ConsultantOct 2006 – Nov 2007
Provided medical device development and manufacturing project management and ISO 13485 process development services.
- Architected an ISO 13485 compliant virtual organization for a Class I medical device startup. Included Quality System and web infrastructure to automate processes and record generation for production of GLP compliant clinical devices. Documented and procured all components for clinical devices.
- Developed and implemented an ISO 13485 certified production system for sterility process challenge device manufacturer completely automating all process and record generation from order entry to shipping.
- Managed Class III catheter device development project for delivery of drug eluting bio-absorbable stent with prototype production oversight including custom extrusions, braids, and lamination. Managed Class III nitinol guidewire development project including forming, tip geometry, and hydrophilic coating. Prepared and presented transfer to manufacturing plan for diagnostic marker product. Salvaged sabotaged IT systems.
Director of ManufacturingBC Tech, Santa Cruz CAFeb 2004 – Oct 2006
Responsible for all Production including Project and customer relationship management, materials and supply chain, sustaining engineering, oversight of QMS, production equipment (IQ/OQ/PQ), facilities andclean room operations, and sterilization processing (EO and Gamma). Direct reports were Manufacturing Engineer/Project Manager, Materials Manager and Production Manager.
- Oversaw the production of Class I, II and III medical device products including surgical tools, knee implants, catheters, drug delivery systems, and pulse oximeters.
- Increased customer satisfaction by implementing single point of contact customer relationship management, QAD MFG/pro ERP system, and streamlining all production processes to ensure efficiency and compliance.
- Managed the manufacture, distribution, recall and rework of combination device for clinical trial. Diagnosed pressure sensing issue and generated rework protocols.
- Managed all manufacturing customer relationships including proposal generation and agreement negotiation.
- Partnered with customers to generate component specifications, Manufacturing Process Instructions (MPI) and batch record documents for products transferred to manufacturing.
- Led all customer quality, CE marked and UL certified product audits, and had significant involvement in all ISO audits.
Director of OperationsResolution Medical, Pleasanton CAOct 2000 – May 2003
Provided mechanical design and manufacturing engineering, managed design control and supply chain to support development of a Class I non-invasive EKG system that accurately localized the origin of arrhythmias or ischemic zones. Assisted in planning of corporate infrastructure, staffing and budget requirements as relating to the business plan.
- Designed and documented passive and active electrode panels, cables, and connectors. Was able to convince high volume supplier to produce prototypes. Also had to restructure documentation on the spot to get attention. Conducted supplier quality audits.
- Designed and built prototype enclosures and built final prototypes of data acquisition holter system. Included machining clear polycarbonate enclosures.
- Architected web-systems for design control and to collate and report clinical trial data. Clinical data was imported from Word forms utilizing custom macro.
VP, OperationsInfo-One Technology, Campbell CA.Aug 1999-Feb 2000
Was asked to temporarily manage operations until a replacement with insurance industry experience could be hired after providing some web development and exhibiting advanced customer relationship and project management expertise. Company was developing a web portal to sell specialized insurance products and providing web development services targeted at large insurance providers.
- Generated customer proposals, agreements and statements of work for development of customer "virtual storefronts".
- Salvaged an online community development project for Sun America by clarifying statement of work and regaining control of contracted resources. Directly managed developers to drive project to completion.
OwnerSpotmartJul 1998 – Aug 1999
Web and database design services specializing in rapid prototyping and deployment of database driven applications.
Director of EngineeringWolfe Engineering, Campbell CA.Mar 1997-Feb 1998
Built and managed a Design Engineering Department and restructure Document control to created new revenue generating design services and documentation products. Designed a Direct Liquid Injection (DLI) module and generated weldment quotes, designs and documentation. Direct reports where Mechanical Engineers and Designers. Group was downsized due to industry downturn.
- Implemented ISO 9000 compliant Document Control procedures and developed design and quality standards. Established a foundation for Visual manufacturing ERP system implementation and corporate restructuring.
Supervisor, CESWatkins-Johnson, Scotts Valley CA.Oct 1993-Mar 1997
Managed Customer Engineering Specials (CES) and provided sustaining engineering support for existing APCVD product lines. Direct reports where Mechanical Engineers and Designers.
- Upgraded chemical delivery system designs for WJ-999 and WJ-1000. Incorporated features to allow configuration changes without design modification and updated components with more cost effective alternatives.
- Provided a better customer experience and faster design cycle for specials by starting the Customer Equipment Specials (CES) design group, including implementing processes for design feasibility, project proposals, and metrics.
- Lowered material costs influencing commodity teams to switch to updated, less expensive valves and MFCs. Cultivated a strategic relationship with critical turnkey supplier reducing manufacturing overhead for expensive gas boxes.
- Leveraged engineering, design and documentation expertise as a member of the Oracle ERP implementation team.
- Completed TQM (Six Sigma) training course.
Mechanical EngineerNovellus Systems, San Jose CA.May 1992-Sep 1993
Designed and documented the layout and subassemblies for an automated clean room interface for semiconductor wafer processing equipment.
- Solved unique design challenges by using railway rotary damper as novel and inexpensive method to smooth pneumatic actuation motion, and aviation air bladders to seal chamber doors. Designed vacuum cast aluminum chambers saving cost over traditional machined chambers.
Mechanical EngineerMedical Composite Technologies, Soquel CA.Aug 1990-Apr 1992
Responsible for design, manufacturing and sustaining engineering functions for a composite wheelchair product. Design aluminum extrusions, injection molded parts, mechanical assemblies, weldments, castings, and assembly fixtures.
- Reduced component costs by investing in tooling for higher volume manufacturing processes. Converted machined components to extrusions, castings and stampings to reduce machining operations.
R&D TechnicianMCM Laboratories, Inc CA.Jan 1990-Mar 1990
Designed and built Class III prototype delivery catheters for coronary laser angioplasty systems. Supervised assemblers and refined production equipment. Participated in in-vitro laser testing. Operations ceased due to lack of funding.
EDUCATION
Bachelor of Science: Engineering Technology, Mechanical OptionDec 1989
California Polytechnic State University, San Luis Obispo.
Training / Certifications
Carnegie Leadership for Managers
American Management Association Manager Effectiveness Program
Building a Cohesive and Well Executing Leadership Team
Franklin Time Quest
Six Sigma Green Belt
SOFTWARE
Languages: VB.NET, ASP.NET, HTML, XML, JavaScript, SQL, VBA
Databases: SQL Server, Oracle, Progress, Access
ERP Applications: QAD MFG/Pro, Oracle, Epicor
Server Applications: Exchange, IIS, Active Directory, DNS
Business Applications: Word, Excel, PowerPoint, SharePoint, Lync, Acrobat, Adobe Creative Suite
Development Environments: Visual Studio
CAD: Autocad, SolidWorks
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