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Sr. New Product Development / Compliance Engineer Resume

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SUMMARY:

  • A highly enthusiastic professional with expertise in project management and design engineering with over 20 years of experience in small, medium, and large organizations, and a history of successful management with outstanding vision for development.
  • Hands - on leadership in effective project, people, and business management, developing feasible product &design strategies, cost optimization, cost reduction, and delivering quality products below financial budgets and on/before delivery schedules.
  • Highly adaptive to new environments, develops & maintains mutually beneficial relationship with suppliers, vendors, and cross functional teams, internally & externally to deliver maximum productivity, efficiently.
  • A self-starter, quick learner, motivator, leader, mentor, and a problem solver with a strong sense of finding solutionswho is also reputed to consistently meet and beat project deadlines.
  • Highly attentive to details, effective management of multiple tasks simultaneously and is a productive leader. Also noted for completing projectsat or below estimated cost withoutany quality compromise.
  • Mechanical engineer, design engineer, development engineer, design & manufacturing coordinator, project engineer, project manager, business development engineer, Quality Management System, ISO 9000 certified Lead Auditor, Solidworks, ProEngineer, and ProEWildfire.

PROFESSIONAL EXPERIENCE:

Confidential

Sr. New Product Development / Compliance Engineer

Responsibilities:

  • Design new & redesign the existing medical surgical metallic implants and tools (screws, plates, rods, tools, etc.) for the Spine, CranioMaxilloFacial, skull, and trauma.
  • Develop new designs to replace older designs by reducing the opportunities for failure during or after the surgery.
  • Verify the existing designs for performance; validate the processes, products, and the design qualifications to meet with the FDA compliance and regulatory guidelines. Also involved in process qualification and validation, DOE, DQ, OQ, IQ, & PQ.
  • Start from concept to production of the small and medium implants as well as medical surgical tools.
  • Project included plastic graphic cases, titanium metallic implants, and the surgical tools as well as power tools.
  • Research, develop, and analyze new designs, create prototypes, conduct preliminary testing, and even involved with the clinical trials of the newly developed product.
  • Involved in the FDA remediation for the verification & validation activities to ensure the compliance with the FDA QSR 820.30 for the Design controls, CAPA activities, Quality audits, and internal audits.
  • Cross functional coordination with the manufacturing, complaint handling unit, marketing, and regulatory teams.

Confidential

Sr. Cost Reduction Engineer

Responsibilities:

  • Develop new designs to replace older designs by reducing parts& sub-assemblies, changing material, reducing cost, w/o compromising quality, verify & validate the design input/outputs and transfer it to production.
  • Designed and implemented an automated grommet installer on the condenser press (From ‘W’ shape to formed condenser), created 3 combinations of materials and grommet profile to reduce the product cost by $ 8.8 million annually.
  • Projects included plastic injection molded parts, tubing, sheet metal parts, stamping, die cutting, forming, rubber bushing & gaskets, foam, refrigerant linecrimp connectors, liner forming, cutting, powder coating of parts.
  • Used AS400 (JD Edwards), Siemens Teamcenter software, & stage gate processes to manage projects, design & develop, review, verify, validate & then transfer the design to the production.
  • Developed multiple alternative solutions to address the challenges arising due to manufacturing problems, high reject rates, process repeatability. Implemented these solutions on the active production line and tested and evaluated the test products for improved functionality, quality, and cost compared to the previous designs.
  • Utilized DFMA cost reduction software by elimination of parts & process step thus reducing the overall cost of the product.
  • Created charts & power point presentation to justify the change to management, to pin point the $$ savings by implementation of the new projects that reduced the cost, improved product reliability & functionality.
  • Redesigned the grommet material and profile to eliminate the problems on the automated loading of the grommets.
  • Worked on multiple possible layouts for the high side redesign for the top mount and bottom mount refrigerators to extend the redesign cost savings over the projected annual sales of 2.2 million units.
  • Closely work with manufacturing, operations, marketing, overseas production facilities, suppliers, quality, reliability group, internal test and prototype labs, & purchasing departments to efficiently come up with robust designs that deliver the cost savings, and more reliable product.

Confidential

VP of engineering

Responsibilities:

  • As a VP of engineering, led the engineering team to design, prototype, test, and manufacture high pressure breathing air and CNG compressors, Mentor associates, effectively managed people & projects, met deadlines below the budget.
  • Involved in new product development (NPD) and conductedproduct design from concept to completion.
  • Different phases involved managing projects, people, &design using solidworks software, reverse engineering of the existing products, prototyping phase, setting up new production lines considering the lean manufacturing aspects, and the product testing. Established design parameters, time & cost goals, created solid models, assemblies, drawings, designed& implemented the test study plans. Lead the team of engineers, and manufacturing associates to produce the end product.
  • Implemented the lean manufacturing practices on the existing as well as the new production lines.
  • Communicated throughout the development process with the various internal departments, external vendors, as the end users.
  • Created a budget, managed the production, material, as well as personnel cost during the entire product development.

Confidential

Sr. Mechanical Engineer

Responsibilities:

  • Involved in Project management &design and development of ahigh volume medical/cosmetic device for home use which uses short beam, short span laser to eliminate facial wrinkles.
  • Involved in new product development (NPD) and complete product design from concept to completion.
  • Different phases involved managing projects, people, &design using CAD software, prototypes, interference studies, thermal, drop &optical testing. Created solid models, assemblies, drawings, designed&implemented the test study plans.
  • Altered the designs after the proto types to address any issues for cost effectiveness, and ease of assembly.
  • Coordinated and supported electrical team for the layout of the PCB and interfaces of the model.
  • Different materials involved plastic injection molded parts, sheet metal, heat sinks (machined, die cast, and MIM), foams, rubberized materials for seals. Also lead and conducted FMEA for the product.
  • Lead and coordinated the use of In Mold Decoration for a dead front display to give an artistic look to the product.
  • Lead, & coordinated with manufacturing to ensure the product was designed with DFM considerations.

Confidential

Product/Design Engineer

Responsibilities:

  • Managed and lead several projects for design and development ofhigh volume medical products, consumer electronics and appliances, military equipment, biomedical devices, oxygen concentrators, heart monitors, disposable medical devices&electromechanicalenclosures both involving new product development and product redesign.
  • As aProject leader/design engineer, designed and/or redesigned products from specifications or concept till completion & also, provided transitional support to the production as well as after design support;domestic & international.
  • Various projects steps included concept phase, design phase, design review phase, prototype phase, analysis & testing, final product packaging,compliance of the prototype with the regulatory agencies like CE &UL; debug prototypes and products for design improvements or cost reduction and/or ease of manufacturing and/or assembly.
  • Involved in resource management, people, finances, budgets, and project phases management in timely manner.
  • Used the ERP (Enterprise Resource Planning) software to effective track & manage the projects.

Confidential

Sr. Mechanical Engineer

Responsibilities:

  • Designed customized PDA for an overseas military project. Designed parts included sheet metal, machined components, and plastic. Closely coordinated with the electrical design interface, suppliers, as well as the manufacturing department to ensure seamless transition from design and development to production.
  • Modified existing products to reduce cost by modifying the assembly process, consolidate multiple parts into fewer parts, eliminating assembly steps, and redesigning the products with more technologically advanced materials to provide better functionality.
  • Involved in rigorous testing of the prototypes. Also created master assemblies, models, detailed & exploded views for the drawing using Solidworks software & coordinated the built with manufacturing.
  • After the complete concept change by the customers, successfully delivered the finished & assembled working prototypes from new concept to completion within 6 months.

Confidential

Sr. Mechanical Engineer

Responsibilities:

  • Designed portable vehicular adapter for the radios used by the US Air Force. Parts included sheet metal, machining, thermofoam and plastic. Coordinated with the electrical design to ensure interference free design, created master assemblies of the ProE models, detailed & exploded views for the drawing using ProE Wildfire & coordinated the built of the final product with internal manufacturing as well as external assembly vendors.
  • Successfully designed product within 5 week rigorous project schedulefrom concept to completion and acted as a ProE system administrator, developed OrCAD to ProE database transfer procedures.

Confidential

Sr. Mechanical Engineer

Responsibilities:

  • Designed and developed complex plastic injection molded and sheet metal parts for 3 digital projectors including the indicator light pipes, illuminated keypads, elevation mechanisms, labels, wiring harnesses using ProEngineer. Also involved in thermal issues doing heat transfer analysis.
  • Performed analytical studies for the mold flow analysis on the button trees due to variable cross sections. Also worked with the electrical engineering to ensure interference free design.
  • Conduct the first prototype builds; implement the changes to the parts and assemblies for production.
  • Coordinate with various compliance and regulatory agencies for the requirements to launch the product worldwide, and designed all the labels including the regulatory labels for the projectors.

Confidential

Sr. Research Engineer

Responsibilities:

  • Designed and developed complex plastic injection molded and sheetmetal parts for medical blood gases/electrolyte equipment involving optics modules as well as fluid (vacuum & liquid) systems.
  • Designed the fixtures and jigs to support production lines for leak free fluid filling stations, set up and maintained production lines. Created and maintained CAD models, assemblies, & assembly drawings.
  • Involved in instrument design & all development activities including sustaining engineering as well as pilot production of the new products.
  • Developed appropriate architecture, part designs, material selection, supplier sourcing, resolved complex mechanical design issues, FEA, design of experiments and vendor audits and assessments.
  • Installed, upgraded and maintained the ProEngineer software platform for design-engineering department. Also assumed the role of system administrator for ProEngineer system.
  • Conducted internal ISO 9000 audits for ISO 9000/FDA compliance and created reports to identify the misalignment between the policies and procedures.
  • Modified existing products to cut the material & production cost by eliminating the process, manufacturing, & assembly steps, making the product more profitable to the organization.

Confidential

Sr. Design/Project Engineer

Responsibilities:

  • Successfully designed product from conception considering the manufacturing aspect for easy assembly. Met cost and quality goals and delivered reliable product by deadline to market.
  • Efficiently considered severe environmental usage for the “career grade’ and NEBS compliance due to extensive usage of GBIC and Fiber Optics interfaces in the product.
  • Studied and analyzed current market interfaces and fixtures to make our product work with the existing layout at a customer’s facility.
  • Utilized Pro Engineer to achieve flawless design for performance, quality and reliability of product.
  • Directed day-to-day operations of the projects as well as the vendor relations in quest of better materials and processes beneficial to the organization.

Confidential

Sr. Design Engineer

Responsibilities:

  • Designed complex plastic injection molded and sheet metal parts for cellular phones.
  • Analyzed clearances, interferences and tolerance stack ups for individual parts and sub-assemblies.
  • Determined right tolerances on parts and optimized design to make it cost effective and simplify assembly and manufacturing processes using ultra-fine tolerances.
  • Effectively created designs from concept and through stages of prototyping tools to the final refined product into hard tool to handle production quantities of over a million units, to include interchangeability capabilities.
  • Coordinated with other functional areas and vendors to resolve problems and locate most cost effective and reliable design and materials.

Confidential

Sr. Design Engineer

Responsibilities:

  • Led a team of design engineers and achieved the project completion prior to the due dates and successfully developed a Macro to automate the manual tasks.
  • Successfully converted OrCAD databases to Pro Engineer models without additional customized software.
  • Involved in design of sheet metal, plastic, foams, casting parts for home appliances like refrigerators, washers, dryers utilizing lean manufacturing practices during the design phase, eliminating the un-necessary and value added tasks.
  • Incorporated from the design phase to eliminate unnecessary waste during manufacturing by creating least amount of assembly features and/or processes.
  • Also developed the appliances with the sealed fluid systems with efficient thermal transfers.
  • Reviewed design issues related to mass production, eliminated the steps that can cause waste during the manufacturing process, as well as, eliminated and resolved problem from the designs.
  • Conducted analytical problem solving by running extended pilot runs to realize, understand, review, and rectify the problems during the production runs.
  • Studied possibilities of using different materials and design techniques to upgrade existing designs.

Confidential

Sr. Product Engineer

Responsibilities:

  • Served as liaison between design, manufacturing and marketing departments.
  • Evaluated and implemented solutions based on customer returns/complaints on new and existing products.
  • Established new quality standards for new products and located new subcontractors and vendors for outside manufacturing. Identified alternate manufacturing materials or processes to reduce cost.
  • Efficiently trained employees at subcontractor facilities for quality in manufacturing.

Confidential

Design and Development Engineer

Responsibilities:

  • Designed new products and enhanced existing products to improve the performance, functionality & reduce end product cost. Worked on several projects to reduce cost for existing product to in corporate newer manufacturing process, materials, as well as elimination of certain assembly steps from the assembly line, analyzed, problem solved, and created new product standards for lower cost of production. Product line included batteries for cellular phones, pager, laptop computers and radios.
  • Effectively coordinated with customer, suppliers, and other functional departments and manufacturing to ensure product design, development, and process expectations are met under the budget.
  • Conducted concept and design review and created models utilizing Pro Engineer for plastic injection molded and sheet metal parts. Performed cost analysis at a product level prior to manufacturing.
  • Conducted engineering, proto and pilot builds for new products.Collected data to meet the internal specs, evaluated the product for six sigma. Initiated Engineering Change Requests & Notices. (ECR’s & ECN’s)
  • Created parts and assembly drawings, procedures and build aids for manufacturing/assembly lines to support production staff and coordinated availability of right fixtures for manufacturing.
  • Reviewed inspection reports and samples, built prototype samples to attain qualification and approval by safety department, quality department and customer.

Confidential

Sr. Engineer& Manager of QA

Responsibilities:

  • Successful Department Head (Quality Assurance) managed equipment sizing, quality specifications and standards, product quality improvement and statistical methods for product inspection.
  • Developed software to study process variation in heat treatment furnaces and failure mode of product during process that successfully detected gray areas in manufacturing.
  • Effectively supervised production and inspection staff, machine shop, and raw casting finishing department.
  • Products involved heavy metal equipment and castings for the cement mills, mining industry equipment.
  • Conducted defect analysis and examination of products to identify appropriate methods of fabrication, molding and casting and machining of heavy and light components.
  • Developed and maintained beneficial working relationships vendors and suppliers and provided technical support from pre-sale to post-sale implementations and troubleshooting problems.

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