The Consumables Design Engineer is responsible for designing, testing, and validating new consumable products in partnership with cross-functional engineering teams. This role translates product requirements into scalable, manufacturable consumable components and assemblies that meet customer needs, production demands, and FDA regulatory expectations. Based in Sunnyvale, CA, this role is part of the R&D Consumables Team, which leads the development and verification of Cepheid's consumable components and plays a critical role in ensuring product quality and performance.
In this role, you will have the opportunity to:- Work on consumables engineering projects through the full development lifecycle-from concept to launch and transfer to Manufacturing-ensuring alignment with customer needs, production demand, and FDA requirements.
- Partner with Assay R&D, Chemistry R&D, Systems Integration, Operations, and Quality to drive innovation and support new product development.
- Develop consumables components and assemblies using CAD, engineering drawings, FEA, rapid prototyping, and verification testing to define part specifications and apply DFM principles to simplify parts, reduce cost, and ease assembly for scale-up.
- Maintain design documentation, risk assessments, and verification/validation records to ensure compliance with medical-device quality and regulatory standards.
- Support lab and automation setup through vendor coordination, fixture design, SOPs, control plans, test method development, and quality control procedures.
The essential requirements of the job include:- Bachelor's degree in engineering (Mechanical, Material Science, Plastics or related field) with 1+ years of related work experience or Master's degree in field with equivalent experience.
- Experience working with part design and development of plastic components and assemblies for mass production. Strong skills in SolidWorks or equivalent; ability to produce models and detailed engineering drawings, SOPs, control plans, and test records.
- Practical experience with rapid prototyping (3D printing, CNC), building test fixtures, and executing verification tests.
- Familiarity with DFM principles, supplier interactions, and part/equipment qualification.
- Hands-on, detail-oriented mindset with the ability to iterate quickly, prioritize tasks, and learn new tools and processes.
It would be a plus if you also possess previous experience in:- Basic FEA/tolerance analysis skills and the ability to interpret results to inform design decisions.
- Understanding of automation and assembly processes for mass production, including automated fixture and tooling design, PLC/robot integration, quality control integration, and transfer to high-volume manufacturing.
- Working knowledge of Polymerase Chain Reaction (PCR) or other biological applications of fluorescence-based techniques.
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.
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.
The annual salary range for this role is $93,000 to $128,000. 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.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
