NPI Manufacturing Engineer
On-siteSunnyvale, California, United States
Job Summary
Develop and release manufacturing processes and EFTs for new accessories while ensuring they meet quality standards through CPK analysis and process capability data. Conduct EFT qualifications to validate equipment performance, develop and validate test methods for product quality, and create work instructions for assembly and test processes. Resolve failures of varying complexity to identify root causes and implement solutions that improve yield and manufacturability. Coordinate with design, clinical, quality, and regulatory teams to ensure compliance and support Supplier Engineering, Purchasing, and Planning functions. Assist in product design reviews focusing on DFX methods and train the manufacturing team on new content.
Required Qualifications
- Exceptional communication skills, both written and verbal
- A continuous improvement mindset
- Basic knowledge of process controls, including Six-Sigma, CPk, etc.
- Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)
- Exceptional organizational skills and proven ability to work on fast-paced projects simultaneously
- Minimum BS degree in Mechanical or Biomedical Engineering
- Able to travel periodically to suppliers or Intuitive manufacturing sites
- Current proof of vaccination against certain diseases including COVID-19
Desired Qualifications
- Excellent problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments
- Excellent technical skills in prototyping, tooling development, and troubleshooting
- Demonstrated ability to effectively design experiments, solve problems and implement them in manufacturing
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