As a key team member within the Infusion Systems and Applications (ISA) team you are responsible for creating and implementing innovative mechanical design solutions for infusion pumps to address customer needs.
Critical Responsibilities
o Develop statistically valid tests and test protocols to verify that designs meet product requirements. o Conduct test method validation (TMV) to ensure tests meet Quality standards o Execute verification testing as defined by test protocols and document results using common Good Documentation Practices (GDP) as defined by the FDA. o Assist in root-cause investigations when necessary o Update design documentation (i.e. drawings and solid models) using SolidWorks and SolidWorks PDM as the need arises o Remain in compliance with training requirements
Key Qualifications, Knowledge and Skills o Must be self-motivated, with good interpersonal and communication skills o Capable of analyzing and solving complex problems through innovation, collaboration and perseverance. o B.S. in Mechanical Engineering and at least three years of experience in the design, development and testing of mechanical devices. Experience with electromechanical and/or medical devices is preferred o Experience developing 3D models using Solidworks, Pro/Engineer (Creo) or equivalent. o Experience using statistical methods such as normality tests and confidence interval calculations. Experience with Minitab is preferred. o Demonstrated root cause analysis and problem-solving skills.