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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