Process Engineer

Location
Fremont, CA
Salary
Competitive
Posted
July 19 2017
Ref
52153BR
Position Type
Full Time
Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.


Position Summary:

This position is responsible for supporting transfer of new product design and or processes from R&D to manufacturing; execute validation studies, engineering studies, and support process improvements for ongoing production. The position requires utilization of both technical knowledge and lean concepts to drive overall process validation activities ensuring that the resulting finished products meet all required safety, quality, and manufacturability by a robust design control process.

Key Responsibilities:

  • Design and execute engineering and validation studies
  • Execute required process validations from raw materials to finished product stages that includes equipments, packaging, and shipping
  • Coordinate implementation of complex manufacturing processes and train operators
  • Provide technical support and decision making related to manufacturing processes
  • Streamline new and existing manufacturing processes and implement practical process improvements
  • Ability to multi-task and lead small working teams
  • Ability to conduct DOE and analyze large set of data through statistical analysis
  • Communicate executive summaries to peers and management in a timely fashion

Minimum Requirements/Qualifications:

  • BS/MS in scientific discipline with 6-7 years diagnostic industry experience
  • Experience in process validation, documentation and reporting is required
  • Knowledge of ERP systems and basic cost accounting
  • Experience with lean manufacturing and six-sigma desired
  • Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485.
  • Demonstrated ability for technical proficiency, problem solving skills, collaboration with other departments, and ability to manage multiple projects or assignments.
  • Ability to present and communicate (oral and written) information in a clear manner.
  • Experience in computer skills such as Word, Excel, and PowerPoint.
  • Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets.
  • Experience in manufacturing, product transfer or product support functions.
  • Project management and leadership skills
  • Experience in use of statistical programs including DOE
  • Good understanding of Design Control elements and considerable experience with manufacturing process validation.

At Thermo Fisher Scientific, each one of our 50,000 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.