Manufacturing Process Development Specialist
2 days ago
The ideal candidate will play a critical role in developing and optimizing manufacturing processes for our continuous glucose monitoring systems.
- Develop and optimize manufacturing processes for CGM systems, ensuring efficiency, scalability, and cost-effectiveness.
- Provide technical support for the production team, troubleshooting and resolving process-related issues.
- Ensure processes comply with regulatory requirements and quality standards (e.g., ISO 13485, FDA).
- Lead and participate in continuous improvement initiatives to enhance process reliability and product quality.
To be successful in this role, you will require:
- Bachelor's degree in Engineering, Chemistry, Biotechnology, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in process development, preferably in the medical device or biotechnology industry.
- Proven experience with continuous glucose monitoring systems or similar technologies is highly desirable.
- Strong understanding of manufacturing processes, including chemical, mechanical, and electronic assembly.
- Proficient in using process development tools and software (e.g., CAD, Minitab, statistical analysis tools).
- Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements for medical devices.
- Six Sigma Green Belt or Black Belt certification is a plus.
- Relevant professional certifications (e.g., ASQ Certified Quality Engineer) are advantageous.
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