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Danaher Corporation Process Engineer - Consumables Automation in Newark, California

Cepheid – Dream. Drive. Do.

Process Engineer – Consumables Automation

All Shifts

6 openings

Cepheid Location Newark, California, United States of America

At Cepheid, we are passionate about improving health care through faster, more accurate diagnostic tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, as we develop rapid groundbreaking solutions to solve the world’s most complex health challenges.

Our associates are involved in every stage of molecular diagnostics ­ ­­– from ideation and innovation through development and delivery of life-changing advancements in healthcare-associated infections, sexual health, critical infectious disease, virology and oncology applications. For more details, visit us at www.cepheid.com or follow us on Twitter. (@CepheidNews)

As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.

POSITION SUMMARY:

The successful candidate will use their industry experience to design and develop and monitor assembly processes for medical device manufacturing.

They will evaluate current capabilities, available technology in the industry, and product requirements to develop new and improve current assembly methods and processes. Use statistical analysis to monitor assembly processes and drive continuous improvement in collaboration with a diverse and highly talented engineering team. This is a hands-on position involving process characterization, validation (transfer to production) and process monitoring, must be able to interface well with other engineers, scientists and operations personnel. Experience with automated assembly equipment and high-volume manufacturing is required.

ESSENTIAL JOB RESPONSIBILITIES:

  • Design and perform process characterization studies & DOE’s to develop new and/or improve existing assembly processes.

  • Design, test, and validate new automation processes and/or designs in collaboration with a diverse functional engineering team.

  • Write Verification/Validation protocols (I/OQ, PQ) and related technical reports to support the transfer of processes into Production.

  • Partner with cross functional teams to evaluate design and processes at concept phase and define manufacturing processes.

  • Develop new and/or improved processes for parts and assemblies through the application of theoretical and practical engineering.

  • Assist in failure investigations and root cause analyses as they relate to process performance.

  • Use statistical analysis, and hands-on bench or line testing to characterize attributes, process performance, and equipment assembly characteristics.

  • Generate documentation including Operating Procedures, Engineering Studies and reports.

    TRAINING RESPONSIBILITIES:

  • Complete all assigned and required training satisfactorily and on time

    MINIMUM REQUIREMENTS:

    Education and Experience (in years):

  • Bachelor’s degree in field with 5+ years of related work experience OR

  • Master’s degree in field with 3+ years of related work experience OR

  • Doctoral degree in field with 0-2 years of related work experience.

    Knowledge and skills:

  • Hands on experience with high volume automated manufacturing equipment.

  • Working knowledge of GMP, ISO, and FDA rules and regulatory requirements. Automotive, aerospace, or other regulated industry experience may be considered.

  • Proven experience with DOE creation, root cause analysis, process engineering, failure investigations and automated assembly equipment.

  • Experience in process development, acceptance testing and qualification of equipment.

  • Excellent communication skills. Must be proficient in document preparation and editing, including detailed test planning and report writing. Excellent verbal and written communication skills.

  • Proficiency with MiniTab, JMP and Microsoft Office applications.

  • Experience with creating BOMs, product specifications, and engineering drawings interpretation (GD&T).

    PREFERRED REQUIREMENTS:

  • BS in Mechanical, Plastics, or Manufacturing Engineering or equivalent combination of education and experience to perform at this level.

  • A minimum of 4+ years overall related engineering experience within medical device or a regulated industry.

  • Project management experience would be a plus.

  • Quality Management System experience preferred.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

About Danaher

As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.

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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