Position Summary & Responsibilities: The Principal Engineer, Reagent Engineering will work within the Reagent Engineering Equipment Project team. This team is responsible for the manufacturing equipment used to produce a complex medical device and provides project management and technical expertise related to the manufacturing equipment. + Main accountabilities are to lead and manage equipment related projects and to provide Solidworks / AutoCAD expertise related to equipment design / modification. + Act as administrator for Solidworks PDM system. + Develop documentation such as equipment master records, equipment drawings, parts lists, etc. as required. + Manage change control process and other compliance related documentation for projects. + Collaborate with Manufacturing, Purchasing, and Quality to lead projects and ensure the optimum manufacturing process in terms of keeping manufacturing moving. + Organize and lead meetings as required to support project timelines. + Develop and submit CAPEX requests for projects when required. + Address unplanned requests for Engineering support as directed by management. + Support projects or tasks required to keep manufacturing running and to ensure quality product is being shipped to customers. + Evaluate new technologies. + Participate in the development of long-term strategies for equipment and process improvements. + Drive continuous improvement of manufacturing equipment. Education, Skills, & Experience: + Bachelor’s Degree in a technical field with8+ years of engineering experience preferred. + High School Diploma with 12+ years of engineering experience also accepted + Technical Certification / Associates Degree with 10+ years of engineering experience also accepted + Masters Degree with 5+ years of engineering experience also accepted + 5+ years of experience working with automated processes and machinery. + Must have strong ability to use Solidworks / Autocad programs. + Solidworks PDM experience is preferred. + Project Management experience is preferred. + Ability to collaborate professionally in a cross-functional team environment. + Knowledge of FDA/ISO regulations and equipment validation is preferred. + Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook). + Must have strong communication and interpersonal skills. + Must have strong analytical and problem-solving skills. #LI-US#biojobs