Engineer Sr I - Manufacturing - (Mechanical & Electrical)

 Requisition ID:          62333 Title: Engineer Sr I - Manufacturing - (Mechanical & Electrical) Division: Arthrex California Inc (US03) Location: ACI Santa Barbara CA (US26) Salary Range: Salary Minimum: $109,250.00 Salary Maximum:  $172,500.00

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. To provide Manufacturing Engineering support to ACT Production Operations, Quality Engineering, Supply Chain and Product Design teams to achieve business goals.  Provide Sustaining Manufacturing Engineering support and to lead projects: involving commercialization of new products; defining assembly and mechanized equipment; improvements to equipment; process performance improvements and data collection; increases in productivity and production capacity; ongoing yield improvements and reduction of costs. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

 

Essential Duties and Responsibilities:

• Define and release manufacturing Work Instructions to guide the assembly operations.
• Provide production process support on manufacturing technical issues daily.
• Partner with Quality Engineering in support of Quality Management System (QMS) requirements involving medical device manufacturing and ISO-13485.
• Develop procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data and perform Root Cause / Corrective Actions.
• Support new product development /design transfer by leading process development and validations by participating in DFx, including Design for Manufacturing, Assembly & Test.
• Drive automation to replace manual processes where economically feasible.
• Support new product development & project management for mechanical and electrical designs thru all phases of the design process.
• Develop and support a continuous improvement culture by utilizing lean principles to enhance quality, operational efficiency and cost.
• Develop and maintain Master Validation Strategies and Master Validation Plans for component manufacturing, device assembly and data collection.
• Lead the design, development and test of new equipment including gathering user requirements, designing equipment mechanical and electrical systems, developing equipment specifications, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, Bills of Materials (BOM) and training of operators.
• Work with suppliers to determine product specifications and arrange for purchase of equipment, materials, or parts and evaluates products according to specifications and quality standards.
• Draft and execute validation protocols and reports including Installation, Operational and Process Qualifications (IQ, OQ, PQ) for equipment and mechanized processes.
• Design, develops, and manages tooling and fixtures. Coordinates quotes and procurement of new tooling with suppliers.
• Perform Gage R&R and Process Capability Statistical Analysis.
• Support the maintenance of equipment and tooling once released to production through troubleshooting, repair tracking, and analysis of impact to the validated state.
• Introduce and support new equipment, products, and processes utilizing industry standard project management tools and techniques.
• Develop an understanding of current manufacturing processes and identify targets for improvements in operational efficiencies, data collection / trending, SAP work order transaction.
• Lead process improvement projects through Design of Exper