This Product Development Engineer role has an emphasis on the design and development of balloons and extrusions from concept and ideation, through commercialization for client companies. In this role, the product development engineer is responsible for the execution of the Balloon & Extrusion Business Unit strategic plan. This individual will create manufacturing processes, component specifications, and design control documentation in support of internal and client project needs. In addition, this individual will interface with internal and external customers as the subject matter expert in balloon and extrusion focused device technologies. MIS is looking for someone who is driven and exceptionally organized with strong analytical skills that can work independently to build a world class product offering from the ground up.

Duties and Responsibilities

Assists with writing proposals for existing clients to achieve new deliverables within an existing phase or as a part of ongoing efforts.
Works with process development team to design, draft, and procure balloon molds and extrusions to yield initial prototypes to stakeholder specifications
Ensure product QMS adherence through LHR/BHR Manufacturing reviews
Develops and maintains balloon recipe, extrusion, and mold outputs to ensure specification control and compliance lot to lot
Understand base extrusion outputs and controls for material processing to yield acceptable balloons
Designs and implements new methodologies, materials, machines, processes, or products to bring concept to market, including essential product and process documentation.
Contributes to execution of protocols and reports as needed to support program activities, including Design Verification and Process Validation.
Conducts feasibility studies of the design to determine ability to function as intended.
Maintains detailed documentation throughout all phases of product development.
Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
Participates in client meetings; Proactively communicates with team to ensure an ongoing two-way exchange of information.
Drives optimization and efficiency improvements to achieve desired quality, throughput, and yield.
Maintains standards of excellence in all Product Development processes.
Any other duties as assigned.

Midwest Interventional Systems Inc

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Product Development Engineer (Balloons and Extrusions)