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Staff Diagnostic Consumables Engineer

Company: Cepheid
Location: Sunnyvale
Posted on: November 22, 2021

Job Description:

Make an immediate impact on a global scale!At Cepheid, leader in molecular diagnostics, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert-- System, we've taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. The work we do every day will change patient care around the world! Be inspired knowing you're part of the team helping to diagnose the most challenging diseases. Learn about the Danaher Business System which makes everything possible. The Staff Diagnostic Consumables Engineer will apply their experience with product development to transform product requirements into sustainable, large-scale consumables production. Use your knowledge of mechanical design, detailed characterization of consumables, materials, automation, and injection molding to engineer custom solutions, improve current designs, and enable large scale manufacturing of consumables for the medical device industry. This position is part of the Consumables Engineering and will be located in Sunnyvale, CA. The Consumables Engineering team fosters an innovative culture that encourages working cross functionally with different departments to work on different types of problems.In this role, you will have the opportunity to:

  • Develop and/or enhance part attributes to improve manufacturability and achieve cost reductions; work with design engineers to optimize design drawings and supplier manufacturing processes so that high quality parts are consistently delivered. Promote a culture of structured problem solving by proactively identifying risks in the design of processes, equipment, and methods associated with consumables manufacturing and work with cross-functional team to design quality into the equipment or process design rather than relying on inspection to detect non-compliance with design or process intent.
  • Use statistical analysis, hands on experience with material selection and characterization, prototype testing, design for excellence (DFX), assay and/or system integration, design verification and validation to transition designs from the Concept phase through Design and Development, and into Production. Determine and lead the execution of the most appropriate testing to address process and system level performance issues that arise during cartridge consumables development. Develop and document business practices, processes, procedures, and work instructions required throughout all phases of development through manufacturing.
  • Establish working relationships with vendors for outsourcing of engineering services, equipment design, analytical testing of consumables and/or development of final test requirements to ensure products meet specifications.
  • Lead failure investigations and root cause analyses as they relate to consumables part performance in high speed automation environments.
  • Lead and/or actively participate in group meetings and be a technical point person in project teams and provide written and oral reports and updates to senior and executive management. The essential requirements of the job include:
    • BS in Mechanical Engineering, Materials Science, Bioengineering or related area, with 8+ years of related work experience or equivalent combination of education and experience to perform at this level.
    • Industry experience in medical device consumables or other regulated product industry and extensive knowledge of quality management systems (QMS) and good manufacturing practices (GMP).
    • Experience in failure investigations, troubleshooting to resolve complex system interoperability problems, design control processes (e.g. identification of user needs, translating to design input requirements, design and development, design verification, etc.) , production change control processes, creating BOMs, production specifications.
    • Extensive knowledge of Failure Mode Effects Analysis (FMEA) and Statistical Process Control (SPC), and Design of Experiments (DOE), data analysis software such as Matlab, R, Minitab, or Excel in order to conduct statistical analyses on collected data.
    • Experience being technical point person in cross-functional project teams, leading moderate to high complexity projects, and driving consensus. Experience in mentoring and/or coaching interns and junior team members. It would be a plus if you also possess previous experience in:
      • Experience with plastic injection molding and part design, high volume manufacturing processes, including machining, extrusion, molding, ultrasonic welding.
      • Experience in project management fundamentals and people management is a plus.
      • Proficiency with GD&T (Geometric Dimensioning and Tolerancing), quality measurement technique, and SolidWorks.
      • Basic machining skills are a plus Cepheid, a Danaher 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 is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, and results-oriented. Danaher is committed to competitive compensation that typically has key components including base salary, and variable annual incentive compensation based on personal and company performance.When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation. If you've ever wondered what's within you, there's no better time to find out.

Keywords: Cepheid, Sunnyvale , Staff Diagnostic Consumables Engineer, Engineering , Sunnyvale, California

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