Job Overview
We are seeking an experienced NPI Engineer to lead and manage new product introduction projects from concept through production ramp-up.
* Collaborate with cross-functional teams to develop and optimize manufacturing processes
* Develop and execute validation plans and risk assessments
To be successful in this role, you will require a strong understanding of validation protocols and quality systems, as well as 3+ years of experience in a regulated manufacturing environment. A degree in Engineering (Mechanical, Biomedical, Manufacturing or related discipline) is also essential.
Key Responsibilities:
* NPI Project Management: Lead and manage NPI projects from concept to production ramp-up
* Collaboration and Teamwork: Collaborate with design, quality, and manufacturing teams to ensure smooth project execution
* Process Optimization: Develop and optimize manufacturing processes to improve efficiency and reduce costs
* Validation and Risk Assessment: Develop and execute validation plans and risk assessments to ensure compliance with regulatory requirements
* Design for Manufacturability: Support design for manufacturability initiatives to ensure that products can be efficiently manufactured
Requirements:
* Education: Degree in Engineering (Mechanical, Biomedical, Manufacturing or related discipline)
* Experience: 3+ years of experience in a regulated manufacturing environment
* Skills: Strong understanding of validation protocols and quality systems