The role
0301Assist in developing and releasing manufacturing processes and EFTs for new accessories
02Ensure processes meet quality standards.
03Manage and examine data for CPK and process capability, and implement improvements based on data
04Conduct EFT qualifications to ensure readiness for production, validate equipment performance and reliability
05Develop and validate test methods (TMV) to ensure product quality and compliance.
06Document and report validation results
07Work closely with design engineers and clinical engineers to understand user needs and clinical requirements
08Coordinate with quality and regulatory teams to ensure compliance with industry standards and regulations and support Supplier Engineering, Purchasing, Planning and Quality teams to resolve line facing issues
09Resolve failures of varying complexity, of both process and hardware nature.
10Identify specific root cause and implement solutions to improve yield/manufacturability
11Assist in product design reviews with a focus on DFX methods
12Create and revise work instructions for assembly and test processes, and train manufacturing team on new content
