The Sr. Device Development and Commercialization Engineer will support end-to-end development of electromechanical devices that interface with disposables, with a focus on infusion pumps that utilize subcutaneous infusion sets and syringes. This role will lead and support design verification and validations activities for infusion pump systems. The role will be the functional SME and technical liaison with internal and external stakeholders. The engineer position within Product Development and Science and Technology will represent the organization in supporting the design, development, analysis and testing of electromechanical hardware/disposables interface.

• Working knowledge of electro-mechanical devices
• Develop and execute design verification plans, and author verification reports
• Conduct effective root cause analysis to investigate issues relating to Electro-Mechanical devices and their interfaces to disposables
• Support the development of system, subsystem and interface design requirements
• Support development and maintenance of traceability among design inputs, design outputs, verifications, and validations. Assists/ supports the identification and implementation of product and process improvement. Develops and or manages infusion pumps system interface traceability matrix.
• Ensures quality and effectiveness of key results of projects within function through sound process design and improvement, early risk assessments, frequent testing supplemented with engineering analysis and implementation of fallback strategies.
• Established strong verbal, written, and interpersonal communication skills with an ability to interface at all levels of the operation environments.
• Participate in design reviews and provide feedback on mechanical designs.
• Ensure compliance with medical device industry standards and regulations.
• Collaborate with internal and external stakeholders in the support of industrialization of consumables in manufacturing.