Director of Engineering
Content
Robert T. Alvarez 4617 Bermuda Ave, San Diego, CA. 92107 Cell 760-832-3320 ~ Residence 619-225-8112 ~ [email protected]
OBJECTIVE Seeking within the medical device industry a position in either manufacturing or product development HIGHLIGHTS OF QUALIFICATIONS * Proven Expertise in Product Development, Operations, Engineering Management an d Sales/Marketing * International and Domestic Experience with Companies ranging from Startup to $ 1.4 Billion in Annual Sales * Experienced in Venture Capital and Acquisitions * Chinese and Far East Sourcing and Manufacturing since 1997 PROFESSIONAL BACKGROUND Raincross Group Inc/Riverside, CA 2/08 to Present Managing Partner - Medical Devices * Contracted by Johnson & Johnson Centacor Division to return as Core Competency in Plastics Design & Manufacturing for a product launch of a new auto injector that was being developed and produced in Oxford England and the J&J Swiss Operat ion. This was successfully launched July 2009. Continuing work on high producti on tooling starts in 2010. * Spent over a year working on advanced catheter technology. The work was toward s lean manufacturing and the advancement of coiling technology. * Design and material selection process on a safety syringe and an IV Port. * Review of a large medical sub-contractors' production lunches for Baxa and Aci sts in Tijuana facility. * Served as Acting Director of Engineering to Nypro Healthcare Baja to reorganiz e and establish engineering support for their assembly and molding operation. A new tooling center was established and new engineering staff was hired. Customer 's services were Acist Medical Systems and the launch of a new syringe productio n line for Baxa Corporation. * Assisted in the design and modification of design for DFM on a safety syringe and a safety IV injection port. The safety syringe program is being launched in Europe and production tooling is being built in 2009. Production is slated for 2 010. Solace Therapeutics Inc/Carlsbad 5/07-2/08 VP of Engineering Joined this medical device start-up in the middle of a PMA study to develop a ba lloon product for woman inconstancy. Identified adverse issues and made several design changes. A second and third generation products have been designed and a ssembled for clinical trials in 2008. Solace failed its initial PMA study and the California R&D center was closed and moved back to Boston. Raincross Group Inc. /Riverside, CA 1/03 -5/07
Managing Partner in a startup (3-year-old) consulting firm * Tooling and start-up of a Chinese/US assembly for a cardiovascular arterial de vice for a major medical device company. * New designs in coil, braided wire and composite catheter and the development o
f the manufacturing processes. * Micro-Catheter and Micro Medical Devices design and manufacturing. * Established business relationships with several US Medical Device Contractors and Chinese suppliers resulting in several million dollars in annual sales. * Granted as sole representative in the US & North America with Ace Mold & Plast ics. United Plastics Group/ Chicago, IL 3/00- 1/03 VP of Engineering and Technology for $350 million medical device subcontracting start-up funded by Aurora Capital . * Oversaw all engineering responsibilities and the conversion of three medical a ssembly plants establishing an Engineering Center of Excellence in Chicopee, MA. Lead a staff of 45 associates in 2 departments. Core focus of role included m arket development and sales of medical device manufacturing capabilities. * Key Executive in establishment of the company's Medical Division. * Lead technical advisor of a group of executives from UPG involved in the appro val of UPG as only one of three global companies to supply Boston Scientific wit h injection molded parts and assemblies. Ethicon Endo-Surgery Inc. (A division of Johnson & Johnson)/ Cincinnati, OH 1/9 5 - 3/00 Core Competency for Plastics Engineering & Design/Principle Engineer * Initially hired into Core Competence for Plastics Engineering & Design Group w ithin R&D to determine the root cause of the failure of the surgical instrument EZ-35 which resulted in death to a patient. EZ-35 had been produced to specific ation. The glass filled nylon gear had failed because it was not produced to the strength required by the original design. * Assigned as Team Leader to put a system in place to assure that bad plastics c omponents could not be produced. The result of five years of reviewing procedure s and technology was a World Wide Standard for launching surgical or any medical plastics part. This standard was adopted by all of J&J's Medical Devices Divisi on in January 2009. The introduction of this system reduced cost of plastics com ponents within EES by 10% to 15%. Division grew from $350 million to $1.4 billi on in sales. * Within 2 month period designed from concept to launch a new Trocar Sleeve. T echnically this could not be produced with any known technology at that time. Ov er a period of 6 weeks a part was produced along with a major breakthrough in in jection molding technology that still stands today as a technological accomplish ment and a foundation for advanced molding of thin wall components such as cell phone housing. * Personally involved with the design review of all new products in R&D includin g: DFM, Design for Manufacturability Function design versus manufacturing requirements Material Technology in metals, plastics and ceramics Work with Supplier Management in reducing lead times, cost of goods, technology transfers to our Juarez, Mexico Plant or sub-contractors Help Supplier Management and operation in designing and setting up a vertically integrated injection molding plant in El Paso Texas PE Handley Walker Inc/ Santa Ana, CA 1/90-1/95
Technical Director for this international consulting firm dealing in Lean Manufa cturing Practices and Application as well as ISO Certification within the US med ical device industry. Customers included Baxter Corporation, Pfizer, Mallinckrod t, Bard and others. Analyzed designs for manufacturability of medical devices as
customers were involved with product recall (483) or complaints that needed to be addressed with the FDA. Corporate Headquarters London, Sales 300 Million Basetec/Carlsbad, CA 1/81-1/90
Consultant in process development of plastics, Carbon-Carbon composites, Metal M atrix composites and advanced materials and processes associated with their deve lopment in conjunction with product development. Clients included Boeing, Northr op, Mallinckrodt, Cobra Golf, GE Turbine Engine Division, Semins Medical, GE Med ical, Sports Medical and Composite Halo Technology, Hexcel, K-2 Ski, Olin Ski Co , Rossignoal Ski Co., Avco Corporation, Baxter Corp. Bentley Division. EDUCATION Bachelor of Science, Plastics Engineering, Lowell Technolgical Institute AWARDS * 1995, Outstanding Merit Award, Cash & Stock Bonus * 1997 Patent Award Trocar Technology, * 1999 Presidential Team Award for Quality & Cost Saving Improvements * 1999 Nominated for Fellowship @ J&J PUBLICATIONS over 70 published articles forwarded upon request PATENTS Three - polymer alloys One - Trocar Seal used by J&J
OBJECTIVE Seeking within the medical device industry a position in either manufacturing or product development HIGHLIGHTS OF QUALIFICATIONS * Proven Expertise in Product Development, Operations, Engineering Management an d Sales/Marketing * International and Domestic Experience with Companies ranging from Startup to $ 1.4 Billion in Annual Sales * Experienced in Venture Capital and Acquisitions * Chinese and Far East Sourcing and Manufacturing since 1997 PROFESSIONAL BACKGROUND Raincross Group Inc/Riverside, CA 2/08 to Present Managing Partner - Medical Devices * Contracted by Johnson & Johnson Centacor Division to return as Core Competency in Plastics Design & Manufacturing for a product launch of a new auto injector that was being developed and produced in Oxford England and the J&J Swiss Operat ion. This was successfully launched July 2009. Continuing work on high producti on tooling starts in 2010. * Spent over a year working on advanced catheter technology. The work was toward s lean manufacturing and the advancement of coiling technology. * Design and material selection process on a safety syringe and an IV Port. * Review of a large medical sub-contractors' production lunches for Baxa and Aci sts in Tijuana facility. * Served as Acting Director of Engineering to Nypro Healthcare Baja to reorganiz e and establish engineering support for their assembly and molding operation. A new tooling center was established and new engineering staff was hired. Customer 's services were Acist Medical Systems and the launch of a new syringe productio n line for Baxa Corporation. * Assisted in the design and modification of design for DFM on a safety syringe and a safety IV injection port. The safety syringe program is being launched in Europe and production tooling is being built in 2009. Production is slated for 2 010. Solace Therapeutics Inc/Carlsbad 5/07-2/08 VP of Engineering Joined this medical device start-up in the middle of a PMA study to develop a ba lloon product for woman inconstancy. Identified adverse issues and made several design changes. A second and third generation products have been designed and a ssembled for clinical trials in 2008. Solace failed its initial PMA study and the California R&D center was closed and moved back to Boston. Raincross Group Inc. /Riverside, CA 1/03 -5/07
Managing Partner in a startup (3-year-old) consulting firm * Tooling and start-up of a Chinese/US assembly for a cardiovascular arterial de vice for a major medical device company. * New designs in coil, braided wire and composite catheter and the development o
f the manufacturing processes. * Micro-Catheter and Micro Medical Devices design and manufacturing. * Established business relationships with several US Medical Device Contractors and Chinese suppliers resulting in several million dollars in annual sales. * Granted as sole representative in the US & North America with Ace Mold & Plast ics. United Plastics Group/ Chicago, IL 3/00- 1/03 VP of Engineering and Technology for $350 million medical device subcontracting start-up funded by Aurora Capital . * Oversaw all engineering responsibilities and the conversion of three medical a ssembly plants establishing an Engineering Center of Excellence in Chicopee, MA. Lead a staff of 45 associates in 2 departments. Core focus of role included m arket development and sales of medical device manufacturing capabilities. * Key Executive in establishment of the company's Medical Division. * Lead technical advisor of a group of executives from UPG involved in the appro val of UPG as only one of three global companies to supply Boston Scientific wit h injection molded parts and assemblies. Ethicon Endo-Surgery Inc. (A division of Johnson & Johnson)/ Cincinnati, OH 1/9 5 - 3/00 Core Competency for Plastics Engineering & Design/Principle Engineer * Initially hired into Core Competence for Plastics Engineering & Design Group w ithin R&D to determine the root cause of the failure of the surgical instrument EZ-35 which resulted in death to a patient. EZ-35 had been produced to specific ation. The glass filled nylon gear had failed because it was not produced to the strength required by the original design. * Assigned as Team Leader to put a system in place to assure that bad plastics c omponents could not be produced. The result of five years of reviewing procedure s and technology was a World Wide Standard for launching surgical or any medical plastics part. This standard was adopted by all of J&J's Medical Devices Divisi on in January 2009. The introduction of this system reduced cost of plastics com ponents within EES by 10% to 15%. Division grew from $350 million to $1.4 billi on in sales. * Within 2 month period designed from concept to launch a new Trocar Sleeve. T echnically this could not be produced with any known technology at that time. Ov er a period of 6 weeks a part was produced along with a major breakthrough in in jection molding technology that still stands today as a technological accomplish ment and a foundation for advanced molding of thin wall components such as cell phone housing. * Personally involved with the design review of all new products in R&D includin g: DFM, Design for Manufacturability Function design versus manufacturing requirements Material Technology in metals, plastics and ceramics Work with Supplier Management in reducing lead times, cost of goods, technology transfers to our Juarez, Mexico Plant or sub-contractors Help Supplier Management and operation in designing and setting up a vertically integrated injection molding plant in El Paso Texas PE Handley Walker Inc/ Santa Ana, CA 1/90-1/95
Technical Director for this international consulting firm dealing in Lean Manufa cturing Practices and Application as well as ISO Certification within the US med ical device industry. Customers included Baxter Corporation, Pfizer, Mallinckrod t, Bard and others. Analyzed designs for manufacturability of medical devices as
customers were involved with product recall (483) or complaints that needed to be addressed with the FDA. Corporate Headquarters London, Sales 300 Million Basetec/Carlsbad, CA 1/81-1/90
Consultant in process development of plastics, Carbon-Carbon composites, Metal M atrix composites and advanced materials and processes associated with their deve lopment in conjunction with product development. Clients included Boeing, Northr op, Mallinckrodt, Cobra Golf, GE Turbine Engine Division, Semins Medical, GE Med ical, Sports Medical and Composite Halo Technology, Hexcel, K-2 Ski, Olin Ski Co , Rossignoal Ski Co., Avco Corporation, Baxter Corp. Bentley Division. EDUCATION Bachelor of Science, Plastics Engineering, Lowell Technolgical Institute AWARDS * 1995, Outstanding Merit Award, Cash & Stock Bonus * 1997 Patent Award Trocar Technology, * 1999 Presidential Team Award for Quality & Cost Saving Improvements * 1999 Nominated for Fellowship @ J&J PUBLICATIONS over 70 published articles forwarded upon request PATENTS Three - polymer alloys One - Trocar Seal used by J&J
