Manuel Anaya Email & Phone Number

San Diego, Ca, Us

Franklin Lakes, New Jersey, Us

Franklin Lakes, New Jersey, Us

Technical investigator for corrective and preventive actions. Product investigations that require complex problem-solving techniques, data analysis, molding analysis, simulation, reliability demonstration test, statistical analysis, complex material analysis and risk analysis. - Recall Z-0026-2018 & Z-1768-2019, Alaris LVP Separated Bezel Boss with a complaint reduction of 98% after improvements implementation.- Recall Z-2909-2020 & Z-2910-2020, Alaris PCU Unresponsive Keypad with a complaint reduction of 100% after improvements implementation.- Recall Z-2736-2020, Alaris LVP Platen Elements with a complaint reduction of 100% after improvements implementation.- Recall Z-2740-2020 & Z-2741-2020, Alaris PCU Battery intermittent connection, with a complaint reduction of 100% after implemented actions.Product development projects for medical systems from the quality function, to achieve compliance to quality policy and regulatory requirements such as ISO 13485, IEC 60601, MDR, CSA, TGA among others. Examples include supporting new product development projects, Support to FDA 510K submission, Compliance support for IEC 60601, verification, and validation planning, sustaining efforts, CAPA support and complaint support. CAPA Ownership of complex technical issues including system, mechanical, software, QMS and those requiring regulatory audits such as FDA 483 audit observations.

Franklin Lakes, New Jersey, Us

Leading and managing mechanical engineering system development projects for BD medical infusion systems (Class II and III, ISO 13485 compliant medical devices). Projects included overseas teams and activities, managing multidisciplinary teams following engineering best practices for the Alaris™ infusion systems, Medley Infusion systems and OUS medical devices.Conceptualize new designs and devices to innovate to provide novel solutions to customer requirements. Implemented new material on Infusion Systems to improve the chemical resistance to cleaning and disinfecting methods. Mechanical lead for regulatory compliance (CSA Third Edition regulatory compliance under IEC 60601, 60721 and 60068).Managed the implementation of the wireless communication card project completed in the UK through a multidisciplinary global team.Introducing improved materials that perform better to cleaning and disinfecting agents. This included reliability testing, verification and validation design of test, testing protocols, molding analysis, process qualification and product validation.Introduction of Valox material to improve chemical resistance to cleaning agents that lead to a reduction of failure rate of 100% for the Alaris PCA and SYR models.Technical Expert for Design For Six Sigma in San Diego, CA

Chula Vista, California, Us

Successfully launched the product development team at SMK Tijuana site. The goal was to build a multidisciplinary group with strong technical skills and soft skills in order to support world class customer needs. Successfully implemented industry standard practices for product development (APQP, DFSS, Agile). Satisfy customer expectations by having constant communication with stakeholders understand their specific needs. Launched products for consumer electronics, automotive, home automation and medical products. ● Successfully developed the product development and product sustaining team with more than 14 engineers including supervisors, electrical, software, mechanical and industrial design engineers.● Lead the innovation efforts on new technologies for product and technology development.● Stablished the first SMK Industrial design team.● Implemented the employee growth plan to retain and nurture talent.● Developed the Hunter Douglas Power View controller devices and the Tesla redundancy control for the steering wheel.

Azusa, California, Us

Lead irrigation rotors and drip product platforms assembled in the Tijuana facility.● Implementation and validation of an automated product assembly line to produce 50M of units per year.● Implementation of an effective plastic molding tool management system.● Product validation under engineering specs, custom application test method development and HALT.● Engineering excellence Award in 2012 and 2013 (2) for Largest Impact of Alternative Material and Engineering Quality Award.

Charlotte, North Carolina, Us

Lead new system and product development in a global environment. Successfully launched products include switches for military and aerospace applications (Esterline, Korry and Boeing), pressure switches, ATV vehicle controls (Polaris, BRP and Harley Davidson), residential door switch modules and custom application products. Some of the qualifications and activities include:● Improve quality of product development by using Six Sigma methodologies for Product Development. ● Improve V&V lead time by implementation of HALT validations for custom applications and agency approvals such as UL, CSA, MIL-SPEC, ENEC, FAA.● Successfully applied for a Patent application for electromechanical device, United States Patent Application 20100236912.● Awarded Black Belt Certification (Certification completed April 2011).

Friedrichshafen, Baden-Württemberg, De

Lead the development of new products and sustaining engineering for key customers (Harley Davidson).● Lead the development of Heated Grip Product for Harley Davidson in 2008.● Successfully participated in the design and development of 7 new products including Switches, Automotive switch modules, POS Keyboards and Hand Controls for Harley Davidson. ● Implementation and support of DFMEA, PFMEA, Control Plan and APQP Parts and products validations.● Awarded Patent: International Publication Number WO 2009/035794 A1

Melville, New York, Us

• Responsible for home and industrial switches, receptacles and connectors.• Validation of Engineering changes, analysis and validation for deviations requested by manufacturing and quality, also reporting cost analysis and cost variance under scheduled basis. • BOM maintenance under ORACLE system.• Design plastic or metal parts for molding or punch press process, new tooling validations, also creating engineering drawings with Co/Create Solid Designer or SolidWorks.• Design team member for the Asenti platform.• Value Engineering applied for saving estimated in 120K.

Master Of Business Administration (Mba), International Business Workshop

Master'S Degree, Higher Management

Diploma, Project Management

Graduate, Engineering