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The Medical Product Quality Engineer must have at least 10 yrs. experience in medical device quality and program management. Represent the customer in order to ensure that the customer’s expectations are clearly understood and being met. Must be capable of directing teams across many organizational areas including design, engineering, tooling, quality, manufacturing, and sales.
Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes.
Responsible for fostering a technical relationship with the customer to encourage additional sales through future product development areas, and facilitate the overall sales cycle.
Requires a 4-yr engineering, technical or management degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
Ability to manage direct reports with varying technical and engineering backgrounds required.
Manage/Coordinate team of engineers and technical staff.
• Manage Programs: Including Technology, Metrology and Cross Functional Teams from Manufacturing, Engineering, Quality and other internal/external resources.
• Represent the customer in order to ensure that the customer’s expectations are clearly understood and being met.
• Provide leadership to technical teams responsible for successful launch of multiple complex programs.
• Service and grow our program base within the Medical / Life Science Industry (Technical Sales)
• Responsible for overseeing the coordination and on-time/in-budget completion of all projects which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes. Oversee all aspects of programs beginning at customer order through to successful transfer to Manufacturing.
• Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
• Ability to participate in product design (R&D) meetings with Medical Customers in relationship with Weiss-Aug Manufacturing technologies.
• Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities, monitor progress and report status to management/customer.
• Facilitate Tooling Kickoff, Specification Review, Design Review and Lessons Learned (Post Mortem) Meetings.
• Oversee the development and input of initial BOM and detailed Routing
• Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
• Jointly responsible for successful transfer of tooling to Manufacturing along with Toolroom and Design Engineering functions.
• Oversee the selection and management of key suppliers as required by project. Oversee the completion of requisitions for approval by management for purchased tooling or other product or services. Interface with outside suppliers to ensure they provide product or services on-time and to specifications.
• Assist in determining needs for additional personnel and/or training in order to meet program needs.
• Identify and facilitate new and/or special equipment needs along with Manufacturing Engineering.
• Interface with customer on technical and schedule-related issues. Ensure program progress is communicated to customer at regular intervals.
• Assist in identifying areas for continued improvement and opportunities to gain organizational knowledge.