Product Launch Specialist
NPI Engineer Role Summary:
As a seasoned NPI engineer, you will be responsible for overseeing the launch of new medical products from concept through to commercial release. This exciting opportunity involves collaborating with cross-functional teams to ensure robust product and process development.
Key Responsibilities:
* Manage NPI projects from early-stage concept through to production ramp-up
* Collaborate with design, quality, and manufacturing teams to guarantee high-quality product development
* Develop and optimize manufacturing processes to meet scalability, cost-effectiveness, and quality standards
* Prepare validation plans, risk assessments, and design transfer documentation
* Support design for manufacturability (DFM) and continuous improvement initiatives
Requirements:
* Degree in Engineering (Mechanical, Biomedical, Manufacturing or related discipline)
* 3+ years of experience in regulated manufacturing or product development environment (ideally medical devices, pharma, or automotive)
* Experience in NPI, process development, or design transfer projects
* Strong understanding of validation protocols (IQ/OQ/PQ), risk management, and quality systems (ISO 13485/FDA)
* Excellent communication and project coordination skills