SUMMARY:

• 12 years’ experience in production and manufacturing environment, out of which 9 years are in medical device manufacturing industry.
• Self - Starter, that learns and grows with a project to ensure timely completion within tight deadlines.
• Experienced project and production manager, worked for Stryker, Synthes and Biomet supplier, managed over 10 projects in addition to shop floor production.
• Performed necessary metrics and estimates. Identified and solved production and maintenance issues.
• Implemented lean practices and performed continues improvement activates, implemented corrective and preventive actions, performed (FMEA) root cause analysis to assess design/production flaws to minimize scrap rates of product.
• Have done process verification, equipment qualifications and process validations.
• Worked in team based environment which achieved team goals in quality, cost, delivery and safety.
• Have selected and audited outside suppliers/vendors, made proposals/recommendations on new equipment purchases.
• Worked with and programmed production equipment (milling, turning, EDM, cleaning, passivation, inspection and other).
• Experienced in wide range of manufacturing technologies, computer and management control systems. Proficient in Windchill, JD Edwards (AS400), Product View, Pro Engineer and MS Office Family of applications.

PROFESSIONAL EXPERIENCE:

Quality Engineer

Confidential

Responsibilities:

• Lead analysis of defect data and CAPA creation / resolution and maintain records as specified by the GEHC quality system.
• Interfaced with Supplier Quality on supplier related defects.
• Conducted root cause analysis on product quality issues, identified trends, and communicated with SQEs.
• Reduced MRB and non-conforming material inventory by 50%.
• Ensured compliance through validation and verification.
• Owner of the NCR and MRB processes. Made quality improvements by utilizing six sigma principles.

Manufacturing Engineer

Confidential

Responsibilities:

• Reduced the total project time and resources involvement by 42% saving the company and average of $260,000. This was accomplished by article tracking excel sheet which captures over 70,000 legacy part numbers its productions steps and part specific information, this data is later used to select the worst case parts depending on its finishing and cleaning processes. The worst case pats once identified are sent for biocompatibility testing.
• Working in a team with chemists and scientists on Global Remediation Quality Plan (GRQP).
• Responsible for determining the need to conduct a residual manufacturing materials study and testing based on changes in materials, processes or product design.
• Identifying and justifying process step equivalencies, updating/creating validation protocols as needed.
• Working with Product Development, R&D on improvements required to the new and legacy product.
• Implementing a controlled manufacturing process that ensures maintenance of biocompatibility.
• Project SME, working globally with multiple manufacturing sites and ERP systems, leading three other engineers and study directors. Point of contact to other GRQP and DHF remediation engineers.

Operations Manager

Confidential

Responsibilities:

• Converted the shop floor to cellular manufacturing, have used the Lean principles by doing so I have reduced the labor force from 142 employees to 131 the quality of the product improved and the company profits were raised by 12%.
• Provided direction to four managers, worked in a team to reduce waste while utilizing the AccountMate ERP system.
• Performed process improvements, conducted time motion studies by measuring various operation factors.
• Improved customer service by organizing and standardizing the techniques used.

Plant Manager

Confidential

Responsibilities:

• In charge of administration, customer liaison, manufacturing engineering, quality assurance oversight, cost estimating.
• Interacted with external customers and suppliers in a quoting and contract review process.
• Performed initial sourcing and qualified suppliers from a technical perspective and effectively communicated customer's requirements.

Manufacturing Engineer

Confidential

Responsibilities:

• Interacted with external customers and suppliers to review designs for manufacturability, by understanding functionality of the part and its features, adding specifications and verifying GD&T was properly applied. Responsiblefor maintaining CAPAs, NCRs, SCRs.
• Point of contact for Stryker, Synthes & Biomet engineers, assisted in product transfer and execution.
• Performed initial sourcing and qualified suppliers from a technical perspective and effectively communicated customer's requirements.
• Managed various production processes/products improvement projects by conducting root cause analysis, conducting time studies, implementing corrective action and evaluating design plans while meeting project deadlines 100% of the time. Participated in root cause analysis of customer/supplier rejections and internal failures.
• Acted as a subject-matter-expert on Trumpf Laser Marker, Agie EDM and Z Corp prototyping machines.
• In charge of writing engineering processes and part specific instructions used as guides for production floor operators and for document control. Performed design for manufacturing reviews, Developed and implemented complete quality plans, including: CMM programming, gage design, procurement and inspection plans.
• Researched, analyzed and selected production equipment; justified overall cost for management.
• Trained other engineers and production associates using a “hands-on” approach, while ensuring a clear understanding of process change protocols.
• Troubleshot production/quality issues during the manufacturing process while following Lean/Six Sigma principles in an ISO 9001, ISO 13458 certified environment.
• Worked with engineers from multiple departments to increase capacity and efficiency across all modules.
• In charge of creating, updating and maintaining the item masters, BOM and routers, etc.
• Reviewed RFQs and helped determine feasibility of projects by estimating labor and related costs and preparing formal quotes for submission. Conducted time studies to evaluate the profits, quoted vs. production.
• Performed validation activities (IQ, OQ, PQ) if required. Been part of the, which Stryker provided to their suppliers.
• Determined impact of ECNs and coordinated changes.
• Have applied the Lean Six Sigma principles which helped reduce the scrap ratio by 15%. Provided and lead cross functional process improvement teams.