Consumables Design Engineer II

Danaher Corporation•Sunnyvale, CA

49d•$93,000 - $128,000•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.