Job Title: Manufacturing Operations Specialist
We are seeking a highly skilled Manufacturing Operations Specialist to join our team. In this role, you will play a key part in establishing and optimizing manufacturing operations for next-generation medical devices.
About the Role
The successful candidate will be responsible for leading and supporting manufacturing process development, optimization, and validation for new and existing medical device products. This includes partnering with R&D, Quality, and Supply Chain to support New Product Introduction (NPI) and design transfer into manufacturing.
Main Responsibilities
1. Develop and document manufacturing processes, work instructions, and test procedures to ensure consistent product quality compliance;
2. Plan execute process validation activities IQ/OQ/PQ associated documentation;
3. SUPPORt The INTRODUCTION Of NEW EQUIPMENT TOOLING FIXTURES including QUALIFICATION CALIBRATION ACTIVITIES;
The Successful Candidate Will Ensure All OPERATIONS COMPLY With Relevant QMS Requirements ISO 13485 FDA CFR PART REGULATIONS.
The Ideal CANDIDATE Should Have Proven EXPERIENCE Supporting NPi AND Process Validation Activities Strong Understanding OF MANUFACTURING PROCESS CONTROLS Root Cause Analysis Risk Management Hands-On Experience WITH Process ValidatiON Equipment Qualification Documentation IN A Regulated Environment Proficiency LEAN ManufacTuring ContinuOus ImprovemenTs Methodologies GREATER experience Gained WORKING Vascular Catheter-Based ELECTROMEchAnical DEVICeS FamiliarITY DFSS Six Sigma Similar PrOCess IMPROVEmenTs TOOlS Previous EXPERIEnCe START-Up Or SCAlE-UP Medical Device EnViRoNmENts Exposure End-To-End PdLC We Are OFFERING Collaborative InnovATive Work CulturE Professional Growth Opportunities Join us And MAKE A DIFFERENCE With Our Team!