6 days old

Consumables Validation Engineer III

Sunnyvale, CA 94086


The Cepheid Consumable Engineering team is seeking a Consumables Validation Engineer III who will apply their experience with manufacturing and development to conduct validations of new injection molded components. This position will support Cepheid€™s factory expansion project due to increasing COVID assay demands. The engineer will also be sustaining tools currently in production by conducting systemic failure investigations. The successful candidate must be able to use their knowledge of mechanical design, materials, and manufacturing automation to improve current designs, interface with vendors and enable large scale manufacturing of consumables for the medical device industry. There are no direct reports to this position.


  • Communicate with external tooling and molding vendors regarding design and development, qualification, or repair activities
  • Coordinate Engineering testing, first article inspections, and qualification activities for validation and verification of consumables components. 
  • Maintain and/or improve existing consumables parts production, with an emphasis on improving manufacturability, achieving cost reductions, and enhancing throughput.
  • Actively participate in group meetings and be a technical point person in project teams.
  • Use 3D CAD modeling, statistical analysis, and hands-on bench or line testing to characterize part attributes, process performance, and assembly characteristics. 
  • Hands-on participation in failure analyses, validations, parts design, and test method development
  • Establish working relationships with vendors for outsourcing of engineering services, equipment design, and analytical testing of consumables components.
  • Enforce high standards for all consumables products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised. 
  • Assist in failure investigations and root cause analyses as they relate to consumables part performance in high speed automation environments.
  • Maintain documentation of Cepheid€™s consumables parts, development, and qualifications according to ISO, CE/IVD, and FDA Quality standards


    • Complete all assigned and required training satisfactorily and on time


      Education and Experience (in years): 

      • BS in Mechanical Engineering, Materials Science, Bioengineering or related area
      • 4+ years of related work experience or equivalent combination of education and experience to perform at this level

        Knowledge and skills: 

        • Must be able 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
        • Experience with failure investigations and root cause failure analysis
        • Basic statistical skills
        • Ability to work cross-functionally and drive consensus
        • Basic knowledge of FMEA, SPC, and DOE 
        • Proficiency with Microsoft Office Suite
        • Demonstrated ability to understand and comply with applicable FDA regulations and company operating procedures, processes and policies

          Physical requirements/abilities: 

          • Ability to lift 10-20 lbs


            • Basic machining skills are a plus
            • Industry experience in medical device consumables
            • Experience with plastic injection molding and part design
            • Experience in project management fundamentals
            • Quality Management System experience
            • Proficiency with SolidWorks.
            • Experience with high volume manufacturing processes, including machining, extrusion, molding, ultrasonic welding.

              Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Biotechnology


Posted: 2020-05-21 Expires: 2020-06-20

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Consumables Validation Engineer III

Sunnyvale, CA 94086

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