Senior Molding/Process Development Engineer | GenomeWeb

Senior Molding/Process Development Engineer

Organization
Cepheid - US
Job Location
Sunnyvale, CA
Job Description

The Senior Molding/Process Development Engineer will be the technical liaison for consumable parts within the Technical Tooling group. This individual will lead the development and sustaining engineering of mold processing and tooling design/development and coordinate with CSET, Planning, Purchasing, R&D, and our outside vendors to implement scientific molding principles into our products.

 

The Senior Molding/Process Development Engineer will also be tasked with engineering support of Production / Planning, Automation Engineering, and quality issues related to consumables. This position will involve a high degree of technical hands-on work, part and tool design, and documentation activities. The successful candidate will be highly organized and comfortable managing multiple projects simultaneously while demonstrating excellent cross-functional communication skills. This individual should possess a solid base of direct technical experience in design and manufacturing of high-volume plastic injection molded products.

 

Responsibilities:

 

• 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 reviews, and test method development.

• Maintain documentation of Cepheid’s consumables parts, development, and qualifications according to ISO, CE/IVD, and FDA Quality standards.

 

Requirements

 

• 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 the scientific injection molding process.

• Proficiency in CAD is a must (preferred: SolidWorks).

• Proficiency in the theory and application of Scientific Injection Molding principles

• 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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