OBJECTIVE:

• Dynamic and experience leader as a Process Development/Validation, Quality & Manufacturing Engineer in the Manufacturing industry with strong experience in process improvement, product development and implementation of six sigma tool.

TECHNICAL SKILLS:

Engineering: Lean/Six Sigma, Project management, Value Improvement, DHF, Validation plan, Validation Summary Report, System procedures, FAT, SAT, PM, IVOT, Process Characterization, New Product, Remediation, FDA Warning letter, Audit, Gap Analysis, PFMEA, ISO, ASTM and ANSI standards, 21 CFR Part 11, Part 210, 211, 820,Fishbone diagram, IQ, OQ, PQ, Test method Validation, Gage R&R, Capability Analysis, technical writing, and cGMP, cGLP, cGCP, Urology, Endoscopy, Lead Management

Software: MS Office Suite, MS Visio, MS Project, Minitab, TE Sampling Plan Analyzer

Equipment: Instron, Smartscope, Keyence, Lloyd, Laser welder, Bonder, Packaging, printing and sealing equipment etc.

PROFESSIONAL EXPERIENCE:

Confidential, Colorado Springs, CO

Validation /Manufacturing Engineer Consultant

Responsibilities:

• Scope work for remediation after a FDA Warning letter. Performed gap analysis in current manufacturing processes and identified gaps for improvements.
• Prepared site for FDA and internal audit while supporting internal and external audits. Provided recommendation to comply with FDA QSR, ISO QMS and other regulatory requirements.
• Generated, Updated and Validated Test methods that include Attribute, Variable, Compendial, Destructive and Non - Destructive Test Methods.
• Reviewed Process validation, MVP, TMV and PFMEA for identification of gaps. Updated these documents and conducted revalidation per current company and FDA standard. Generated leverage reports for validation that meet current standard.
• Reviewed design documentation and generated Design Input Output gap action plans. Closed out minor gaps with a justification report and recommended necessary actions to the R&D team for closing major gaps.
• Updated and validated (IQ, OQ,PQ) current fusing process with a split die bonder equipment. Designed lay out of equipment with value stream mapping to simplify manufacturing.
• Commissioning, installing and Qualification of various equipment (die bonder, hot box, sealers, leak testers) in clean-room. Generated Equipment Specification, IQ, Calibration and Preventive Maintenance documents for these equipment.
• Member of a major CAPA team to investigate and prevent various equipment from running outside of calibrated and validated range. Performed uncertainty analysis and Gage R&Rs on all heating equipment analyzed if they meet/exceed company quality requirements

Confidential, Spencer, IN

Process Validation /Manufacturing Engineer Consultant

Responsibilities:

• Lead packaging VIP opportunities on various legacy catheter products. These projects helped company to reduce cost and maximize profit while continuing to demonstrate quality and Confidential t safety.
• Process development for a new catheter product, which involved leveraging processes from legacy products as well as validating new processes. I gained hands on experience on Bonding, pad printing, cut to length, packaging and sealing.
• Drafted and reviewed E&AS documents for newly acquired equipment (FAT, SAT, Equipment Specification, IQ, EHS, GOI, PM, Calibration Procedures). Also wrote, updated and reviewed FMEA, routers, BOM structures.
• Developed, executed and analyzed studies supporting the development of new process specifications utilizing DOE and statistical analysis tools. Wrote and reviewed validation protocols and reports applicable to new processes.
• Completed equipment installation documents (specifications, drawings, maintenance procedures and qualification protocols & reports). Also worked with vendors and contract manufacturers in confirming equipment and materials delivered meet BSC standards.
• Generated internal quality documentation such as quality plans, standard operating procedures, test method protocol and validation, new equipment calibration and qualification. Executed test methods and wrote report per companies standard procedures. Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management
• Implemented studies and experiments to validate new processes. Develop and revise GOI and operational procedures for new processes and equipment. Assist in the new products introduction and interact with various departments- Operations, R&D, Regulatory affairs and marketing during the selection and implementation of new technologies.
• Communicate to the various departments, in a timely manner, information related to new equipment to betransferred to the facility.Develop project management tools to ensure timely completion of project goals.
• Lead metallurgy activities in the team, which included developing a process for potting, grinding, polishing and etching of the samples. Designed and conducted an experiment to inspect incoming wires from vendor and found wires received were out of spec. This early detection resulted in significant amount of savings to the team.