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.

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