Medical Device Solutions Principal Systems Engineer

Medical Device Solutions Principal Systems Engineer Medical Device Solutions Principal Systems Engineer Battelle, a world leader in research and technology, has an opening for a Principal Systems Engineer in its Medical Device Solutions business (MDS). MDS is a $25MM business focused on the development of medical devices for commercial clients ranging from small start-up companies to large multinational corporations. MDS projects span the full medical device life cycle, from Advanced Development to Device Development to Sustaining Engineering. Job Functions: The Principal Systems Engineer is responsible for leading the systems engineering activities on electro-mechanical medical device (inclusive of software) programs. This engineer understands the influences on medical device development from sources such as regulatory, compliance and ISO 13485 registered quality systems. A broad interdisciplinary background and demonstrated competencies as listed below will be necessary to fulfill this role throughout the life cycle of the program. Strong communication skills are required as this position will entail direct engagement with customers, project teams, vendors, and compliance agencies. This is a leadership role with commensurate responsibilities and expectations. Required Qualifications BS/MS in Biomedical, Electrical, Mechanical Engineering or Systems Engineering  Minimum 10 years overall engineering experience in an interdisciplinary product development environment; 3 years of this experience in a SE role while operating under a registered QS and the FDA QSR  Demonstrated competency in program planning, e.g. developing work breakdown structures, resource planning  Thorough understanding of requirements management; from development through verification and validation; experience with requirements management tools  Working knowledge of ISO 14971:2007; experience in conducting safety risk management activities, e.g. Hazard Analyses, FTA, and FMEA  Experience in the development of the product/system architectures  Working knowledge of safety compliance process (product safety marks)  Experience in the conduct of Design Verification activities  Experience in supporting marketed products Desired Qualifications  Working knowledge of Design Validation activities  Working knowledge of device clinical trials (from the device perspective)  Familiarity of applicable EU New Approach Directives, e.g. MDD, IVDD  Familiarity of regulatory submissions, e.g. FDA 510(k), CE Marking  Familiarity of available industry reference resources, e.g. AAMI, RAPS, INCOSE Battelle is an Equal Opportunity Employer.