Supervisor, Process Application at KARL STORZ Endoscopy America, Inc. in Goleta, CA
The Supervisor, Process Application provides technical leadership within the Machine Shop for current and new product development and ensures product manufacturability and serviceability. This position will also lead the activities in the subsequent design, development, and machining processes associated with the manufacturing of parts for medical devices. The Supervisor, Process Application is responsible for leading activities associated with current and new product development, creating manufacturing plans (manning, equipment, process flow, process validations, and tooling requirements) to transition products from design to manufacturing with a machine shop environment. Develop methods and validates process and tooling with the collaboration of the assigned process developer prior to release. Provide input on manufacturability and service ability of designs, verifying product performance to specifications, statistically verifying process methods, and providing technical leadership to the manufacturing, assembly, and service lines. Position Duties and Responsibilities Leads improvement initiatives by looking to reduce set-up times, reduce cycle times and lead times, improve quality, minimize/eliminate waste, and to optimize product flow. Will work according to Machine Shop key process indicators provided by the Department Manager. Will review Prototype request to determine machinability and/or will advise of change. Works with suppliers to resolve process and/or quality issues. Leads or assists in the evaluation of equipment and materials in support of specified requirements. Works in a concurrent environment to provide technical leadership in the support of product development teams and sustaining activities:
Participating in design reviews and performing / reviewing tolerance analyses. Participating in Kaizen Events to eliminate waste and improve flow. Defining tooling requirements. Performing tool and fixture design. Creating and/or evaluating CNC programs using Esprit CAD/CAM. Leading process design, process development, process instruction documentation, and process validation activities. Assessing and mitigating process risk. Assisting in the qualification and training of support technicians and the training of process operators. Providing technical leadership for support departments. Will work on multi axis machines for process evaluation and troubleshooting activities Project lead and project manager on sustaining engineering and vertical integration initiatives. Will act as Machine Shop representative in product design review and EC approval. Attend MRB meetings as required. Regular attendance is an essential job function. Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KSI's products and services. Knowledge, Skills & Abilities Demonstrated ability to successfully lead process improvements projects involving the analysis of capital equipment and process flow. Demonstrated ability in the use of Solid Works, Esprit CAD/CAM, and Microsoft Office, SAP. Demonstrated ability to develop and design tooling, to develop processes, define process controls, and validate process and product performance. Excellent written and oral communication, in English. Strong organizational skills and the ability to manage multiple assignments. Strong analytical skills and experience in problem solving using statistical methodologies. Be able to multitask in a fast paced environment Working knowledge of Measurement System Analysis and SPC preferred. Strong understanding of tooling and work holding concepts Solid understanding of GD&T. Ability to work in metric unit of measure. Demonstrated ability to successfully lead cross-functional teams in a complex manufacturing / engineering environment. Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) Education and Experience BS in Manufacturing, Mechanical or Industrial Engineering and/or 10
year's equivalent work experience in a machine shop production environment and possess a strong aptitude for process engineering. 5 years' experience (machine shop production or prototype). Certification in the principles and implementation of Lean Manufacturing Strategies coupled with Six-Sigma experience desired. Experience in analytical/problem solving using statistical based methodologies. About the Company
Salary Range:
$80K -- $100K
Minimum Qualification
Process ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Participating in design reviews and performing / reviewing tolerance analyses. Participating in Kaizen Events to eliminate waste and improve flow. Defining tooling requirements. Performing tool and fixture design. Creating and/or evaluating CNC programs using Esprit CAD/CAM. Leading process design, process development, process instruction documentation, and process validation activities. Assessing and mitigating process risk. Assisting in the qualification and training of support technicians and the training of process operators. Providing technical leadership for support departments. Will work on multi axis machines for process evaluation and troubleshooting activities Project lead and project manager on sustaining engineering and vertical integration initiatives. Will act as Machine Shop representative in product design review and EC approval. Attend MRB meetings as required. Regular attendance is an essential job function. Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KSI's products and services. Knowledge, Skills & Abilities Demonstrated ability to successfully lead process improvements projects involving the analysis of capital equipment and process flow. Demonstrated ability in the use of Solid Works, Esprit CAD/CAM, and Microsoft Office, SAP. Demonstrated ability to develop and design tooling, to develop processes, define process controls, and validate process and product performance. Excellent written and oral communication, in English. Strong organizational skills and the ability to manage multiple assignments. Strong analytical skills and experience in problem solving using statistical methodologies. Be able to multitask in a fast paced environment Working knowledge of Measurement System Analysis and SPC preferred. Strong understanding of tooling and work holding concepts Solid understanding of GD&T. Ability to work in metric unit of measure. Demonstrated ability to successfully lead cross-functional teams in a complex manufacturing / engineering environment. Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) Education and Experience BS in Manufacturing, Mechanical or Industrial Engineering and/or 10
year's equivalent work experience in a machine shop production environment and possess a strong aptitude for process engineering. 5 years' experience (machine shop production or prototype). Certification in the principles and implementation of Lean Manufacturing Strategies coupled with Six-Sigma experience desired. Experience in analytical/problem solving using statistical based methodologies. About the Company
Salary Range:
$80K -- $100K
Minimum Qualification
Process ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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