Jason Hsu Email & Phone Number

Palm Beach Gardens, Fl, Us

1. Responsible for all inventory planning and purchases to support 30M revenue sales.2. Manage production orders to support new product launches.3. Lead SIOP.4. Develop Accelus Product Metrics for making supply chain-related decisions.5. Manage Vendor Relationships.

Warsaw, Indiana, Us

In the past two years at ZimmerBiomet, the majority of my time was dedicated to a transfer project at the received site in Palm Beach Gardens. My role in the project was to work with the send site engineers and provided technical knowledge of the transferred processes to the internal cross functional teams so that identified tasks can be completed accordingly. My other responsibilities were... 1. Develop BOMs/Routers, Process Flow Chart and Work Instructions. 2. Develop Process Validation Plan and Report.3. Develop and perform software and process validation protocols. 4. Perform Pilot Run. 5. Support Transfer Quality Plan documentation. 6. Provide training to operators.

Substitute Military Service Branch

Palm Beach Gardens, Fl, Us

During the time at Biomet 3i, I supported New Product and Technology Development in Digital Dentistry for patient specific product from manufacturing engineering aspects.1. Conducted Scanner equipment validations to ensure accuracy, repeatability and conformity of end user needs. 2. Conducted pilot run to evaluate new manufacturing process prior to executing validations. 3. Developed explicit Operating Procedures (OPs), Work Instructions (WIs), Routers/BOMs, and manufacturing Plan/Specifications for productions.4. Developed process flow and performed cost analysis to insure profitability for new products. 5. Implemented a new process line to deliver a new product service. 6. Developed manufacturing assessment plan and Process-FMEA for three digital dentistry projects during design control stage to comply with FDA and ISO regulatory requirements. 7. Provided level 2 technical support to customers.

Dallas, Tx, Us

When I was a project engineer at Epimed, I worked with the manufacturing and quality assurance departments to deliver effective product designs and solutions for interventional back pain management physicians. I am experienced in design control, design history file, risk management, product design with SolidWorks, manufacturing process (UV bonding, injection molding, medical polymer, etc) and process validation (IQ, OQ and PQ), and testing protocols for quality assurance to meet regulatory requirements.1. Enhanced an existing catheter with process/material improvements for better usability and established new customer base in Canada. 2. Designed a new user friendly steerable catheter with an ergonomic handle assembly to reduce doctor’s learning curve and to expand potential market. 3. Conducted design and process verification/validation (IQ, OQ, and PQ) to ensure manufacturability, repeatability and conformity of end user needs. 4. Developed testing protocols, acceptance criteria and risk assessments for quality assurance during design control to comply with FDA and ISO regulatory standards. 5. Developed explicit standard operating procedures (SOPs) for product assembly and revised manufacturing process map to increase quality and efficiency. 6. Published technical reports to document designs and R&D results for executive review and consideration.7. Attended medical device and manufacturing conferences to research new development needs and evaluate potential suppliers for better pricing and distribution.

Master, Biomedical Engineering

Bachelor, Biomedical Engineering