Lead effort to investigate and correct manufacturing problems to insure production continuity. Lead effort to identify, justify, and implement equipment and process improvements to reduce overall production cost. Lead validation activities on all manufacturing equipment and processes.
• Lead and evaluate production problems (equipment / process / product), suggest improvements, and implement solutions.
• Perform analytical and experimental testing to assure equipment, process, and product integrity.
• Lead and execute validation planning, execution (VPP / IQ / OQ / PQ), and analysis of resulting data and prepare summary reports.
• Provide training as required on manufacturing changes and document these changes in the Angiotech Quality System.
• Lead and develop the development / design of special-purpose machinery / tooling / processes to manufacture new products or improve manufacturing efficiency.
• Lead effort to analyze, recommend, and implement improvements in production methods, flow of work, and use of people.
• Provide equipment and process support during introduction of new products into the manufacturing phase, including documentation of BOMs, routers, and SOPs.
• Provide guidance to other Engineers and Technicians to support project completion
• Perform other duties as assigned.
Education: Bachelor’s Degree Required
Experience: A minimum of 2-5 years related experience
Other Knowledge, Skills, Abilities or Certifications:
• Proven technical communication skills, both oral and written.
• Proven ability to demonstrate results in a team environment – both as a leader and as member
• Very good familiarity with office productivity software and experience with statistical data analysis
• CAD experience, SolidWorks preferred
• Experience with FDA and medical device manufacturing
• Experience with metal forming processes and tooling is a plus
• Experience with computer controlled production equipment
• Proficient in mechanical design
Able to lift 20 pounds, manual dexterity to use tools, flexibility to work overhead and mobility to work around equipment.
Angiotech is an Equal Opportunity Employer M/F/D/V/
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