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.
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.