alfred pon

manufacturing and regulatory lead

About

Over 30 years of experience working with small companies that deliver niche medical device products. I have collaborated on product teams that have successfully brought products to the market place. My roles have encompassed every aspect of product development from proof of concept, prototyping, software and hardware testing, production, installation, and training. In my current role, I am serving as the Technical Lead within the Manufacturing Team, taking on a diverse set of activities to support the delivery of the company’s suite of CAD/CAM products to the customer.

Country

canada

City

vancouver

Industry

computer software

Skill

technical support, rapid prototyping, medical devices, manufacturing, fda, product development, customer service, quality assurance, research and development, product testing, management, electronic troubleshooting, ce marking, emc compliance, regulatory compliance, technical documentation, maintenance and repair, field service, fullfillment

Experience

systems engineer

mckesson health solutions

1996-2 - 1997-3 · 1 yr 2 mos

systems engineer

international telepresence corporation

1997-3 - 1999-2 · 2 yrs

research and development engineer

xillix technologies

1989-5 - 1996-2 · 6 yrs 10 mos

manufacturing and regulatory lead

vorum rc

2017-1 - Present · 9 yrs 9 mos

* Execute work orders of subassemblies and incoming inspection of critical parts. * Perform QA testing on products prior to shipping and deployment at customer sites. * Source and test replacement parts for obsoleted components in our products. * Outsource Spectra 3D white light scanner to contract manufacturer. * Redesign the controller on a 3 Axis CNC milling machine with ethercat based solution. * Perform custom electronics modifications on 4 Axis CNC milling machine to enhance performance. * Validate software driver updates to scanner and carver products. * Fill temporary role of supply chain management, inventory management, specifying Bills of Materials, and warehouse organization. * Direct company on all regulatory compliance issues.

product engineer

vorum rc

1999-2 - Present · 27 yrs 8 mos

* Lead Engineer for product design, manufacturing, Quality Assurance, and installation of 3D laser scanners used for fabrication of cranial remolding orthosis. * Provides Technical Support for international customer base of 3D laser scanner hardware and software for cranial application. * Performs hardware and software testing & validation for company's suite of CAD/CAM products. * Performs QA testing on products prior to shipping and deployment at customer sites. * Repairs and maintains 3D scanning products for prosthetics, orthotics, and footwear. * Advises company on regulatory compliance issues including Electromagnetic Compatibility (EMC), CE Marking, CSA/UL safety testing, and FDA regulations. * Collobrates with team members on development of new 3D scanning products.