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Thermo Fisher Scientific Product Engineer-Hardware in Santa Clara, California

Job Title: Product Engineer- Hardware

Requisition ID: 106931BR

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

Santa Clara / Bio production Division

How will you make an impact?

The Product Engineer - Hardware (PE) will be the Technical Product Owner throughout Product Lifecycle from the transfer from R&D to NPI, and then from NPI to Sustaining. He/She will lead the Engineering Design Changes/Product Features (Electrical, Mechanicals & Firmware) that will improve the Bioprocess Equipment and Automation Performance, Quality, and Reliability. The PE will collaborate and leverage Product Engineering (HW/SW), Supplier Development, Product Test, Process Engineering, Advanced Manufacturing Test/Automation, Product Data Management, and Manufacturing Engineering partners to drive Product Design Improvements and triage defects from factory and/or customer failures.

What will you do?

  • Participate on new product introduction teams as the technical representative for Manufacturing

  • Prepare written work instructions and manufacturing documentation

  • Independently troubleshoot manufacturing processes that are not working. Rapidly identify problems and make corrections.

  • Design and validate manufacturing processes and analytical methods

  • Write validation reports upon completion of the project

  • Work in cross-functional teams to support process and material changes

  • Lead teams in process risk assessments

  • Present technical project reviews to Management

  • Train production/QC staff on transferred products, technologies, procedures and protocols

  • Independently plan designed experiments, testing several variables in order to develop manufacturing processes

  • May be required to perform other duties as assigned

How will you get here?

Education:

  • Mechanical, Manufacturing or Technical Engineering degree or equivalent demonstrated experience

Experience:

  • Minimum 5 years' experience in Process/Manufacturing Engineering in a production environment

  • Qualification experience - IQ, OQ, PV, PQ

  • Past experience in Biopharmaceutical industry with cGMP, FDA and ISO13485 guidelines is preferred

  • Experience with lean manufacturing methods and philosophies

  • Experience with engineering standards, testing, SPC and FMEAs

Knowledge, Skills, Abilities

  • Experience with various statistical analysis tools and methods

  • Excellent communication, interpersonal and interdepartmental coordination skills

  • Self-motivated and mastery of problem-solving skills using investigative tools (5 Why, Fishbone, Fault Tree Analysis, 8D, etc.)

  • Excellent technical writing skills

  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project, Visio)

  • Proficiency in DOE and FEA and associated software tools

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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