PROCESS ENGINEER (MEDICAL DEVICE)

About the role

The process engineer will be responsible for managing the end-to-end transfer of medical device products from external business partners to our manufacturing facility. This role involves overseeing the transition of manufacturing processes, ensuring compliance with industry standards, and coordinating cross-functional teams to facilitate smooth and efficient product transfers.

Key responsibilities

• Develop and implement new manufacturing processes for new disposable medical devices.
• Perform Design of Experiments for process definition and to optimize equipment parameters for new and/or existing processes.
• Create documentation to support new and improved manufacturing processes.
• Use of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are 'born lean and capable'.
• Manage new products implementation including new BOM and Work Instruction creation, validation run activities coordination.
• Execute process validation (IQ, OQ, PQ) and validate methods for inspection for verification and process controls during product development stage, perform data analysis and report compilation.
• Collaborate to ensure proper documentation is completed to meet quality systems requirements (e.g., GOIs, BOM's, Routers, FMEA's, etc.).
• Coordinate and execute all relevant engineering change work flow, drawing and documentation update in accordance to the SOP.

About you

• Bachelor's Degree (minimum) in Engineering (Mechanical, Electrical, Biomedical, Industrial), or a related field.
• Medical device experience including familiarity with FDA regulations (e.g., 21 CFR 820), ISO standards (e.g., ISO 13485, ISO 14971), and other applicable medical device manufacturing standards.
• At least 3-5 year(s) of working experience in manufacturing or project management, preferably in medical device assembly industry.
• Process Development; equipment validations and process characterization and validation experience.
• Quality Assurance/Control Experience: Understanding of design controls, validation protocols (IQ/OQ/PQ), and risk management methodologies.
• Experience ensuring that products meet all quality and regulatory requirements throughout the transfer process.
• Experience with failure mode analysis (FMEA), root cause analysis, CAPA (Corrective and Preventive Actions), and risk management processes.
• Strong background in process design, process optimization, and troubleshooting during scale-up.
• Understanding of medical device manufacturing processes and equipment, including assembly, sterilization, packaging, and labeling.
• Expertise in writing, reviewing, and maintaining SOPs, work instructions, and manufacturing documentation.