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Danaher Corporation Senior Biomedical Engineer (Consumables) in Sunnyvale, California

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Senior Engineer - Biomedical (Diagnostic Consumables) is responsible for applying their experience with injection molded plastics and product development to transform product requirements into sustainable, large-scale consumables production. Use your knowledge of mechanical design, materials, automation, and 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 team and will be located in Sunnyvale, California.

In this role, you will have the opportunity to:

  • In support of New Product Development (NPD) efforts, apply engineering knowledge for prototyping and hands-on lab testing to develop and 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.

  • Use hands on experience with material selection and characterization, prototype testing, design for manufacturing (DFM), assay system integration, and validations to transition designs from the Concept phase through Design and Development, and into Production.

  • Coordinate and drive new consumable part and process qualifications from inception through completion in accordance with FDA and ISO guidelines.

  • Implement high standards for all consumable products such that the design intent, quality expectation, and finished medical device function are never compromised.

The essential requirements of the job include:

  • A Bachelor’s degree in Engineering with 5+ years of related work experience OR a Master’s degree plus 3+ years related experience OR Have a Doctoral degree (in Engineering) plus 0-2 years of experience

  • Ability to understand applicable FDA regulations and Company operating procedures, processes and policies.

  • Knowledge and experience in design control processes, design of experiments (DOE), interpretation of test results and failure investigation.

  • A successful track record in product development and in transferring product from R&D to manufacturing.

It would be a plus if you also possess previous experience in:

  • Biomedical or Mechanical Engineering experience in a FDA regulated Medical Device or Medical Diagnostics Company

  • Experience with GD&T (Geometric Dimensioning and Tolerancing), quality measurement technique, and use of SolidWorks.

  • Proficiency with data analysis software such as Matlab, R, Minitab, or Excel in order to conduct statistical analyses on collected data.

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 danaherbenefitsinfo.com.

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 DBS tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible!

If you’ve ever wondered what’s within you, there’s no better time to find out!

#LI-JC2

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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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 (https://www.dol.gov/agencies/ofccp/posters) .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 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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