The Staff Tooling and Automation Engineer is responsible for designing, developing, qualifying, and bringing up R&D tooling and automation solutions that support consumables development and assembly. This includes translating consumables design and process requirements into robust tooling, fixtures, equipment, and automated assembly methods that enable rapid development, verification, and scalable manufacturing readiness.
This position is part of the R&D Consumables Team and will be located in Sunnyvale, CA or Lodi, CA. The R&D Consumables team spearheads the engineering of Cepheid's consumable components, tooling, and assembly processes. From developing R&D tooling and fixtures, partnering with vendors to bring up new equipment, and implementing automation for consumables assembly, this department plays a critical role in delivering products and processes that meet or exceed customer needs.
In this role, you will have the opportunity to:- Collaborate with Assay R&D, Chemistry R&D, R&D Lab Operations, Systems Integration, Technical Operations, Manufacturing Engineering, Quality, and external vendors to support Innovation and New Product Development projects, taking responsibility for tooling and automation development from concept through build, qualification, verification, and transfer readiness in a medical device environment.
- Enable consumables development through tooling design, fixture design, equipment specification, CAD, engineering drawings, prototyping, design of experiments, process characterization, equipment qualification, and verification with an emphasis on improving manufacturability, assembly efficiency, process robustness, and cost effectiveness.
- Lead R&D automation efforts for consumables assembly and lab automation including vendor communications, equipment bring-up, fixture integration, standard operating procedures, control plans, test method development, acceptance criteria, and quality control procedures.
The essential requirements of the job include:- Professional education related to Tooling Engineering (Mechanical Engineering, Plastics Engineering, Polymer Science) with 8+ years of related work experience or equivalent experience.
- Proven expertise in tooling design, fixture development, automation equipment development, vendor management, equipment bring-up, and qualification for plastic consumables, assemblies, or medical device products.
- Product and process life cycle experience, including requirements definition, concept development, design reviews, test planning, execution, data analysis, associated documentation, and implementation into scalable manufacturing under design control processes.
- Strong analytical and troubleshooting experience, including understanding of mechanical, automation, controls, and consumables system interfaces, with the ability to quickly analyze, tackle, and resolve equipment, tooling, and process integration challenges in ambiguous and complex situations.
- Demonstrated leadership and collaboration in a cross-functional environment, including continuous improvement, problem-solving, vendor coordination, and hands-on execution to deliver tooling and automation solutions on schedule.
It would be a plus if you also possess previous experience in:- Experience developing R&D automation or semi-automated assembly processes for medical device, diagnostics, life sciences, or high-volume consumables products.
- Working knowledge of plastic injection molded components, mold tooling interfaces, metrology, machine vision, motion control, PLCs, robotics, dispensing, bonding, or precision assembly systems.
- Experience with equipment qualification, process validation, design of experiments, statistical analysis, and documentation in a regulated medical device environment.
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $130,000 to $190,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
