
Process Development Specialist
1 day ago
This role involves driving innovation and improving patient outcomes through the development and implementation of manufacturing processes.
Responsibilities:- Create and implement optimal manufacturing processes and procedures to ensure product performance
- Collaborate with cross-functional teams to develop and maintain manufacturing processes aligned with regulatory requirements
- Develop and review validation plans, protocols, and procedures for successful transfer activities
- Provide engineering support regarding design concepts, specification requirements, and best practices for manufacturing techniques
- Bachelor's degree in mechanical engineering or a related field with 5-8 years of relevant experience
- Strong understanding of manufacturing process validation, Master Validation Planning, IQ, OQ, PQ, and Lean Manufacturing Six Sigma methodologies
- Proficiency in GD&T, interpreting mechanical drawings, and statistical analysis tools such as Design of Experiments (DOE)
What We Offer:
- A dynamic work environment that fosters innovation and growth
- Ongoing training and development opportunities to enhance your skills
- The chance to make a meaningful impact on patient lives
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