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Detail-oriented Senior Manufacturing Engineer with [Number] years of experience. Committed to implementing modern production systems without losing profits and knowledgeable about organizational streamlining. Technically proficient in equipment repairs and maintenance. Resourceful Manufacturing Engineer with [Number] years of experience. Trained in leadership and [Product or service] design with extensive knowledge of [Equipment] maintenance. Successful at cultivating relationships with vendors and clients. Manufacturing Engineer with over [Number] years of diversified design, manufacturing, [Skill] and [Skill] experience in high and low volume production. Extensive background in [Type] engineering. Aggressive at identifying and resolving inefficient procedures and processes. Efficient Senior Manufacturing Engineer with [Number] years of [Area of expertise] experience. Effective at [Skill] and [Skill] with extensive knowledge of [Software] use. Adept at multitasking and dedicated to organization. Senior Manufacturing Engineer experienced working with early stages of product design and medical device development. Background includes over [Number] years of experience in healthcare industry with focus on catheter-based device design and manufacturing.
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Support for Manufacturing Lines
- Resolve issues impacting[KY1] production fulfillment. Write and perform Process Validations (IQ, OQ, and PQs) for introducing or changing[KY2] manufacturing process equipment and renovations to the Controlled Environment Room (CER).
- Monitor bioburden in CER and on products and take action if alert levels are exceeded.
- Author assembly manuals for new product introductions to be used by production technicians.
- Oversee all preventive maintenance activities on tool, jigs, and equipment in Sunnyvale.
Project Management / R&D
- Lead cross-functional teams on outstanding tasks after acquisition of Beacon Endoscopy.
- Program manager for Fine Needle Fiducial product that will be launched.
- Introduce and create complaint process in Sunnyvale for legacy Beacon products.
- Transfer legacy Beacon documents into the Medtronic quality system.
- Train technician, regulatory, complaints, and quality personnel on the Beacon product line.
- Provide design for manufacturing (DFM)[KY3] analysis and support to R&D for prototypes and new products.
- Work with R&D to transfer new products into commercial manufacturing.
Support Quality Management System
- Process engineering change notices (ECOs) for EPD updates, part changes, and process change.
- Support notified body audits and corporate audits.
- Write and execute deviations and non-conforming material reports (NCMR) on catheters and production parts.
- Functioned as project coordinator on new product introductions and new repair introductions that will introduce repairs for new products launched in North America and Latin America.
- Co-introduced estimation process for Gyrus ACMI flexible endoscopes at Olympus.
- Authored disassembly, assembly, and repair manuals for new product introductions to be used by production technicians.
- Led meetings with cross functional team members (documentation, production, quality engineers, and operations) to review Gantt chart, ensure all tasks are on time, and resolve any delays during new product introductions.
- Provided training to technicians, supervisors, trainers, the field and other employees on new products and process changes.
- Conducted engineering trial to proof out repair process for prototype scopes and new products.
- Contributed ideas to engineering management to improve the new product introduction process and participated in the Kaizen project.
- Processed ECNs for EPD updates, part changes, and process changes to the Change Control Board.
- Oversaw temporary change notices to repair scopes that have not been introduced in the US market and prepare manuals, scope parts, tools/jigs, and supervise the technicians during the repair process.
- Wrote validation reports to introduce new test equipment, tools/jigs to the production line.
- Created repair and assembly tool tables to help technicians identify the correct tool to be used per model.
- Created checksheets for Datasweep so that technicians sign electronically and verify that all critical tests and tasks were performed.
- Represented the engineering department at the SP cross functional team meetings to discuss and resolve issues that occurred during the week.
- Mentored associate engineers by answering product or process questions.
- Reviewed documents revisions, BOMs, and checksheets created by associate engineers
- Created ergonomic work stations and efficient (one-way) production lines to lessen traveling (steps) taken by technicians.
- Created tool holders to help organize the tools and jigs in each workstation in the surgical assembly line.
- Assisted process engineer in the medical product Kaizen project by video taping technicians performing their task and analyzing the videos by conducting time studies using Avix software and setting time standards per stage.
- Helped identify and eliminate Muda (waste) in the assembly processes.
San Jose State University - San Jose, CA
San Jose State University - San Jose, CA
- Minored in Mathematics
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School Attended
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- San Jose State University
Job Titles Held:
- Senior Manufacturing Engineer
- Engineer
- Associate Engineer
Degrees
- Master of Science
- Bachelor of Science
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