Process Development Expert
hace 1 semana
Key Responsibilities:
- Support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products
- Provide technical expertise and project leadership in areas such as medical device life cycle management, supplier change management, COGs, process development, validation and production stability
- Review and update applicable product specifications and drawings for legacy products
- Develop and issue change control documentation to address changes in components and/or raw materials requested by suppliers
- Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, as well as manufacturing process improvements
Requirements:
In order to succeed in this role, you will require a Bachelor's degree in an engineering discipline (Mechanical, Industrial, Electrical, Chemical, Biomedical) or sciences. A Professional Engineer License and Lean/Six Sigma Green or Black Belt Certification are highly desirable.
Minimum of 4-6 years of experience in medical device and/or pharmaceutical manufacturing environment is required, with experience in validations: manufacturing equipment and processes, stability or aging.
Strong Project Management skills, excellent communication skills in English (read, write and speak), and ability to develop technical documentation such as: Change Controls, Validation Plans & Protocols, Technical/investigation reports, SOP, etc. are essential.
This is a temporary position, lasting one year.
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