Process Development Engineer

Donatelle Plastics
501 County Road E2

New Brighton, MN 55112

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Process Development Engineer

Overview of Responsibilities:

Engineering Support Responsibilities:

·         Support project team in developing manufacturing processes for new products

·         Develop robust manufacturing processes to be validated, proven out using statistical methods

·         Support/assist project team during process validation

·         Complete tasks efficiently so as to deliver projects on time and within budget

·         Provide design for manufacturability input

·         Work with manufacturing during product/process development to ensure a successful hand-off from engineering to manufacturing

·         Effectively communicate with all team members

·         Work effectively with other team members to ensure high level project goals are met

·         Provide creative ideas and solutions to challenging problems

·         Apply knowledge and past experiences to solve problems

·         Establish effective and efficient manufacturing plans, including work instructions, inspection plans

·         Solve problems using a systematic, logical progression problem solving approach

·         Be a subject matter expert in chosen field(s); use this knowledge to assist and train others

·         Participate in the creation and execution of qualification and validation protocols/plans

·         Work with outside resources, as necessary, to augment Donatelle’s capabilities and capacity

·         Continuously improve processes

General Responsibilities:

·         Responsibility to protect Donatelle confidential information and Intellectual Property

·         Performs other duties as assigned

·         Follows safety requirements as defined in Safety Manual

Preferred Qualifications:

Education/Experience:

·         Bachelor degree in engineering and 5 years of experience or two year technical degree and 8+ years of experience in a manufacturing environment

Other Qualifications and Desired Skills:

·         Experience in a medical device manufacturing environment preferred

·         Knowledge of Injection Molding Processes and equipment, scientific molding methodology, process monitoring systems

·         Knowledge of manufacturing operations such as welding, pad printing, assembly, and bonding

·         Knowledge of thermoplastic and Liquid Silicone materials

·         Knowledge of metal machining processes for materials such as Titanium, Stainless Steel, etc.

·         ASQ Certified Quality Engineer (CQE)

·         Certified Process Validation Professional (CPVP)

Physical Requirements:

·         Ability to work in a general office environment

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