Sr Process Engineer
Medtronic · Humacao
CMCFull-timeCompany career page
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Role summary
Senior Process Engineer position leading process development, optimization, and validation in regulated medical device manufacturing. Responsible for driving continuous improvement, ensuring regulatory compliance, and implementing scalable manufacturing solutions that enhance yield and operational efficiency.
What they're looking for
- Bachelor's degree in engineering (or Master's with 2+ years relevant experience, or PhD)
- Lean Manufacturing and Six Sigma Green Belt or Black Belt certification
- Advanced statistical analysis expertise (DOE, SPC, MSA, process capability)
- Equipment qualification and validation leadership (IQ/OQ/PQ)
- Regulatory knowledge of FDA QSR, ISO 13485, and GMP requirements
- Experience with automation, digital manufacturing, and data analytics tools
- Technology transfer and scale-up experience in manufacturing environments
What you'll be doing
- Provide technical and sustaining engineering support in manufacturing operations and areas
- Lead development, optimization, and innovation of new manufacturing processes and procedures
- Recommend and implement equipment and process modifications to improve quality and production efficiency
- Ensure manufacturing processes comply with regulatory standards and develop statistical process controls
- Collaborate with R&D and product design to ensure process-design compatibility and manufacturability
Privacy & handoff
This role links to Medtronic's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.