Job Description
Job Summary
To understand the Critical to Quality (CTQ) requirements for Medical Device sub-components as defined by both our Internal and External customers. It is our responsibility to transform those CTQ requirements into specifications and analyze all risks associated with the manufacture of those sub-components. By using these specifications, we will work with our internal and external customers and suppliers to design a highly capable, completely validated process to seamlessly transition manufacturing processes from NPID into Operations.
Essential Duties & Responsibilities
• Utilize approved mold builders for all molds, tooling, fixtures, and equipment. Maintains detailed follow-up and progress reports to the Team Leader and Customers.
• Manage and develop molds, tooling, processes, and equipment from placement of customer purchase order, through start-up, process development, first article approval, capability approval, and initial Production Qualification runs.
• Works closely with the Quality Control and Quality Assurance departments as well as internal and external Customers to develop inspection methods, sampling plans, and validation activities focused per Requirements Reviews and CTQ’s.
• Stay current with the latest developments in the plastics molding industry through use of trade magazines, trade shows, supplier visits, technical training, and technical conferences.
• Evaluate quotations from subcontractors and equipment suppliers to determine relevance to scope of the project and CTQ’s.
• Work with Technimark marketing and sales in providing engineering and technical services with regards to tooling and mold design, as well as, estimating manufacturing cost of product to be produced or quoted on when required.
• Ensure processed delivered to Operations are within the parameters of the quotation with specific regards to cycle time, scrap rates, labor requirements, cavitation, capacity, and reasonable inspection quality requirements.
• Analyze, understand and document all the risks associated with new products/processes.
• Estimate modifications through request for quotation on project assignment to ensure efficient production design of tooling and processes; sketched design changes or modifications for designers and provides assistance to ensure expected results.
• Review piece price and tooling costs of manufacturing product.
• Provide assistance and technical expertise to other departments when requested.
Competencies
• Communication Skills
• Punctual/Reliable
• Building Relationships
• Problem Solving
• Time Management
• Bilingual English and Spanish
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