The Sr. Engineer, Ops Integrator for New Product Development will contribute to the development and commercialization of new products and the development of new manufacturing process associated with novel medical devices and device improvements across our Critical Care Business. The Ops Integrator Engineer will support Critical Care Operations by ensuring device design adheres to principles of DFM and leverage existing processes. In this role you will also be responsible for setting up product configurations, coordinating between the project team and the existing supplier base, EW supply chain, and launch phase-in/ phase-out strategy. You will also be the subject matter expert on EW operations integration for the NPD team. You will be responsible for bringing issues related to all aspects of operations from the team into the broader EW organization and will be accountable to the team for performance of appropriate operational and supply chain activities by the extended team members.

Responsibilities:

• Create, characterize and implement new processes or process improvements required for NPD.
• Develop operational strategies to manage complex manufacturing process design, development and validation efforts.
• Lead Ops Integration efforts to complete deliverables necessary for NPD and integration into existing operations.
• Work and effectively communicate in a high energy, cross functional team and multiple site environment which includes product design, regulatory, quality, procurement, configuration management, supply chain, supplier quality and operations to ensure project objectives are met.
• Drive incorporation of technical advancements into manufacturing process and technology employed in the manufacture of both existing and new products.
• Continuously improve existing materials, manufacturability and sustainability.
• Be the subject matter expert in key disciplines related to the manufacture of Class I, II and III medical devices.

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Qualifications

Qualifications:

• Bachelor's degree in engineering discipline is required, preferably Mechanical, Electrical, Materials, Chemical, or Biomedical Engineering.
• A minimum of four years of experience (with a bachelor's degree) in the medical device industry with key technologies and processes related to the assembly and manufacture of Class II or III cardiovascular devices is required.
• Demonstrated use of process excellence methodologies and applied statistics.
• Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN experience leading to manufacturing efficiency improvement.
• Effective knowledge transfer experience.
• Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation.
• Capable of analyzing and solving complex problems through innovative thought and experience.
• Demonstrated strong project management skills leading to cost savings.
• Strong communication and interpersonal skills.