The Senior Tooling/Process Development Engineer will be the technical liaison for consumable parts molding process in the Process Development group. Lead the sustained engineering of existing molds and tooling; coordinate with Production / Planning on the high level management of Cepheid's consumable parts.
The Senior Tooling/Process Development Engineer will also be tasked with engineering support of Production / Planning, Automation Engineering, and issues related to consumables. This position will involve some amount of technical hands-on work, design (SolidWorks), and documentation activities.
The successful candidate will be highly organized and comfortable managing multiple projects simultaneously while demonstrating excellent cross-functional communication skills. Should possess a solid base of direct technical experience in designing high-volume plastic injection molded products.
- Define the requirements for the production of new consumables tooling and parts design by working closely with R&D.
- Coordinate with Production, Planning, and Purchasing to prioritize and drive the qualification and re-qualification of injection molding tooling used to manufacture Cepheid proprietary consumables.
- Coordinate with Production, Planning, and Purchasing to strategically manage Cepheid's High Volume Consumables Tooling program.
- Drive for results - delivering high quality plastic injection molded products in a timely and cost-efficient manner.
- Participate in failure analyses, First Article Inspections, parts design, and test method development.
- Maintain documentation of Cepheid's consumables parts, development, and qualifications according to ISO, CE/IVD, and FDA Quality standards.
- B.S. in Mechanical Engineering, Materials Science, or related technical discipline. Or, equivalent combination of education and experience to perform at this level.
- A minimum of 8 years direct related experience working with tooling design and injection molding process.
- Proficiency in CAD is a must (preferred: SolidWorks).
- Must have demonstrated ability to communicate and coordinate efficiently across multiple functions and employee levels.
- Demonstrated experience designing, coordinating, executing, and documenting complex product and/or process validations and qualifications (IQOQPQ).
- Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes and policies.
- Must possess strong hands-on and direct injection-molding engineering knowledge and process experience.
- Must possess strong leadership qualities and able to work with minimal supervision.
- High aptitude for quickly learning new technologies and open-minded attitude.
- Working knowledge of design of experiments (DOE) and interpretation of test results.
- Must have ability to meet deadlines on multiple concurrent projects.
- Advanced knowledge in MS Excel, Word and Power Point.
- Solid mathematical skills. Basic statistics knowledge required.
- Traveling requirements: up to 10% domestic travel.
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