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:
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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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