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Sustaining Engineering Senior Engineer
Job Field: Government Jobs
Location: OGDEN, UT
Job Type: Full Time
Location: OGDEN, UT
Job Type: Full Time
JOB SUMMARY:
Sustaining Engineering Senior Engineer-120001BP PURPOSE AND SCOPE:Supports FMCNAamp;amp;#x2019;s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Sustaining Engineering Senior Engineer to conduct research and development work on products that are in the production phase of the product life cycle. Engineer to lead and coordinate projects that focus on cost reductions, process improvements, product quality and other patient issue as necessary. DUTIES / ACTIVITIES:This engineer will conduct engineering research in both the Peritoneal Dialysis and Hemo Dialysis Manufacturing Plants, where they will interface with department Engineers, Manufacturing Supervisors, Lineworkers and Department Managers. All work will be focused on Strategic Company and Department goals. The following are required:This engineer will conduct engineering research in both the Peritoneal Dialysis and Hemo Dialysis Manufacturing Plants, where they will interface with department Engineers, Manufacturing Supervisors, Lineworkers and Department Managers. All work will be focused on Strategic Company and Department goals. The following are required: * Leading major and minor engineering projects focused on Product Improvements from inception through Product Release. It will be critical to be knowledgeable of, and apply FDA/ISO Design Control regulations in conjunction with sound engineering principles and good lab practices. * Both Drug and Device regulatory experience with strong technical writing skills mandatory. * Engineering Tests report writing will be an important part of this position. Will develop test methodology, qualification protocols and in some situations conduct testing, demonstrating a willingness to work hands on. * Will author verification and validation protocols and reports and perform necessary analysis. Much of this work will be in conjunction with engineers associated with the Manufacturing departments. Will also interface with the Regulatory Groups to support, and in some cases author, parts of submissions and replies to the FDA. * Will provide technical support to other departments and will interface with the New Product development departments, Marketing and Clinical staff who utilize the products that are built in the Ogden plant. Will interface with the Reynosa and Walnut Creek engineering and manufacturing groups. CUSTOMER SERVICE: * Responsible for driving the FMCNA culture through values and customer service standards. * Accountable for outstanding customer service to all external and internal customers. * Develops and maintains effective relationships through effective and timely communication. * Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Under the guide and supervision of the SE Manager, coordinate all efforts for major projects; lead product realization (concept through release). * Coordinate secondary projects and support sub tasks of other projects. * Execute projects with clear objectives and timely deliverables. * Understand the goals and contents of research projects. * Apply FDA/ISO Design Control regulations to product development. * Utilize Stage Gate and Product Life Management systems to guide project teams in development and implementation. * Effectively lead cross-functional teams on product development and manufacturing problem-solving efforts. * Interface regularly with vendors/consultants. * Self-motivate to improve knowledge related to research projects by continuous assessment of current publications. * Contribute to the generation of ideas and potential inventions to be used to improve existing products and create new products. * Contribute design solutions to complex, multi-disciplinary problems. * Develop and give
Sustaining Engineering Senior Engineer-120001BP PURPOSE AND SCOPE:Supports FMCNAamp;amp;#x2019;s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Sustaining Engineering Senior Engineer to conduct research and development work on products that are in the production phase of the product life cycle. Engineer to lead and coordinate projects that focus on cost reductions, process improvements, product quality and other patient issue as necessary. DUTIES / ACTIVITIES:This engineer will conduct engineering research in both the Peritoneal Dialysis and Hemo Dialysis Manufacturing Plants, where they will interface with department Engineers, Manufacturing Supervisors, Lineworkers and Department Managers. All work will be focused on Strategic Company and Department goals. The following are required:This engineer will conduct engineering research in both the Peritoneal Dialysis and Hemo Dialysis Manufacturing Plants, where they will interface with department Engineers, Manufacturing Supervisors, Lineworkers and Department Managers. All work will be focused on Strategic Company and Department goals. The following are required: * Leading major and minor engineering projects focused on Product Improvements from inception through Product Release. It will be critical to be knowledgeable of, and apply FDA/ISO Design Control regulations in conjunction with sound engineering principles and good lab practices. * Both Drug and Device regulatory experience with strong technical writing skills mandatory. * Engineering Tests report writing will be an important part of this position. Will develop test methodology, qualification protocols and in some situations conduct testing, demonstrating a willingness to work hands on. * Will author verification and validation protocols and reports and perform necessary analysis. Much of this work will be in conjunction with engineers associated with the Manufacturing departments. Will also interface with the Regulatory Groups to support, and in some cases author, parts of submissions and replies to the FDA. * Will provide technical support to other departments and will interface with the New Product development departments, Marketing and Clinical staff who utilize the products that are built in the Ogden plant. Will interface with the Reynosa and Walnut Creek engineering and manufacturing groups. CUSTOMER SERVICE: * Responsible for driving the FMCNA culture through values and customer service standards. * Accountable for outstanding customer service to all external and internal customers. * Develops and maintains effective relationships through effective and timely communication. * Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Under the guide and supervision of the SE Manager, coordinate all efforts for major projects; lead product realization (concept through release). * Coordinate secondary projects and support sub tasks of other projects. * Execute projects with clear objectives and timely deliverables. * Understand the goals and contents of research projects. * Apply FDA/ISO Design Control regulations to product development. * Utilize Stage Gate and Product Life Management systems to guide project teams in development and implementation. * Effectively lead cross-functional teams on product development and manufacturing problem-solving efforts. * Interface regularly with vendors/consultants. * Self-motivate to improve knowledge related to research projects by continuous assessment of current publications. * Contribute to the generation of ideas and potential inventions to be used to improve existing products and create new products. * Contribute design solutions to complex, multi-disciplinary problems. * Develop and give
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