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Job ID :
42679BR
Location :
US - Utah - Logan
:
Job Description
Position Summary: Under the direction of the Manufacturing Engineering Manager to lead the efforts in developing and qualifying new products and processes including the design, construction, and qualification of new products, processes, and equipment. The position is also involved in risk management and increasing product reliability and quality.

Key Responsibilities:

  • Collaborate with other engineers (process, controls, mechanical, etc.) to design, build, and qualify cleanroom manufacturing equipment
  • Fully document designs, specifications, validations, and qualifications per established procedures and ISO standards
  • Establish and manage multiple concurrent project timelines, resources, and budgets to ensure delivery commitments
  • Manage outside vendors (machine shops, integrators, etc.) to ensure compliance with project deliverables
  • Develop strong working relationships with operations personnel to ensure best manufacturing solutions

Minimum Requirements:
  • Experience with engineering tools and methods for core tasks such as experimentation (DOE), risk assessment (FMEA), process control (SPC), and statistical analysis
  • Experience in the specification, validation, and qualification of manufacturing equipment and processes
  • Experience in managing engineering projects including responsibility for establishing and managing budgets and timelines
  • Experience in design and implementation of automated manufacturing systems (high-mix/low-volume production desired)
  • Proficient in technical writing including engineering protocols and reports as well as development and implementation of procedures
  • Medical Device/Biopharmaceutical manufacturing (i.e. GMP, FDA, ISO13485) experience desired
  • Good communicator with interpersonal and interdepartmental coordination skills
  • Self-motivated with good problem solving skills
  • Less than 10% anticipated travel
Non-Negotiable Requirements:
  • MSME w/3yrs or BSME w/5yrs experience in manufacturing equipment design and qualification
  • Proficient in CAD (SolidWorks highly preferred)

Relocation is not budgeted for this role.



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.
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