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Sr Manufacturing Engineer

Boulder, CO 80301

Posted: 09/15/2023 Employment Type: Contract Job Category: Engineering Job Number: 586115 Is job remote?: No Country: United States

Job Description

Pay 45-60 depending on experience

Top 3 technical  skills that you are looking for in a candidates experience:

  1. Process Validation
  2. Design of Experiments
  3. Gauge R&R
Must Have
  • Bachelors of Engineering degree (Mechanical, Electrical, Software or Bio-Medical)

Nice To Have
  • 1. Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4. Process Validation and Computer software validation knowledge
  • • Ability to use statistical techniques to analyze data
  • Automation
  • design of experiments
  • Gauge Repeatability and Reproducibility

Education Required: Bachelor’s Degree in a technical discipline 

Years’ Experience Required: Minimum 4 years

This position is for an Advanced Manufacturing Engineer. This role will support a lead manufacturing engineer during development and validation of new production lines. Responsibilities include, but are not limited to:
  • Support development and validation for new production equipment.
  • Develop and characterize the manufacturing process window and secure process capability across all variation in production materials and processes.
  • Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
  • Define and generate all required documentation in support of manufacturing protocols, reports, changes, and manufacturing instructions. These include Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.
  • Provide engineering support to manufacturing operations and address quality issues arising on the production floor.


Minimum Requirements
  • Bachelor’s Degree in a technical discipline
  • Minimum 4 years of experience required.

Nice to Have
  • Master’s Degree in a technical discipline
  • Medical Device and/or Manufacturing Experience
  • Experience in a medical device manufacturing environment
  • Experience developing vision inspection/verification systems
  • Experience with equipment development and process validation (IQ/OQ/PQ)
  • Experience working with statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis
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