Senior Systems Engineer, Diagnostics Reporting to: VP of Instrument Development
The main responsibilities will include: Understanding the needs of product assay workflow and develop associated Instrument design inputs. Working directly with a third-party partner to develop instrument solutions to meet the design input needs and ensuring they meet key milestones and timelines. Leading project teams and providing technical project management to meet internal stakeholder needs. Ensuring all development activities are in compliance with regulatory requirements, ensuring adherence to life cycle requirements. Development and implementation of design characterization, DOE’s and design verification strategies. Detailed understanding of medical device regulations including ISO, FDA GMP and design controls.
Qualifications and experience Required: Primary degree in bio mechanical engineering / electrical or electro mechanical engineering. Experience in diagnostics and/or medical device product development, supported by relevant IVD business understanding. Strong working knowledge of electromechanical design, requirements definition and V&V activities. Manufacturing experience in a medical device / IVD manufacturing environment with specific emphasis on improvement methodologies Flexibility to travel required, primarily in Europe.
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