Sr Process Engineer
Medtronic Inc
Senior Process Engineer at Medtronic in Humacao, Puerto Rico, responsible for leading process development, optimization, and validation in regulated medical device manufacturing. Drives continuous improvement initiatives while ensuring compliance with quality and regulatory standards across cross-functional teams.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 11 days ago
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