Sr Manufacturing Engineer
5920 Longbow Drive Boulder, CO 80301 US
Job Description
Pay 45-60 depending on experience
Top 3 technical skills that you are looking for in a candidates experience:
- Process Validation
- Design of Experiments
- Gauge R&R
- 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 disciplineÂ
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.
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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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