Senior Manufacturing Engineer
7 days ago
Overview
The Senior Manufacturing Engineer is responsible for leading critical initiatives to develop, setup and qualify manufacturing processes for OdonAssist, ensure compliance with regulatory standards, and drive innovation in our product development efforts. As a key member of the MNHI Technical team, the senior manufacturing engineer will also be involved in maintaining and enhancing the quality, efficiency and scalability of our manufacturing operations. This is an individual contributor role, part of the Engineering team and reporting to the VP of Engineering and Manufacturing. This is a new position and the first one in our small team that will be fully dedicated to manufacturing.
DUTIES AND RESPONSIBILITIESLead the collaboration with external vendors and contract manufacturers to define and develop manufacturing equipment and processes for Class I and II products. This includes process characterization, equipment buy-off, validation, and scale-up activities in compliance with ISO 13485 and FDA regulations (21 CFR Part 820).
Evaluate and enhance existing manufacturing processes to improve efficiency, yield, and cost-effectiveness while maintaining product quality and regulatory compliance for existing products.
Lead initiatives to implement new technologies, processes and materials to advance manufacturing capabilities and reduce costs.
Lead root cause analysis and implement corrective/preventive actions (CAPA) to address manufacturing issues or manufacturing related product complaints to prevent recurrence.
Collaborate with contract manufacturers to develop and review manufacturing procedures, work instructions and other manufacturing documents.
Close collaboration with cross functional team from Quality Assurance, Supply Chain, Regulatory Affairs and contract manufacturers to ensure product and process integrity throughout the product life cycle.
Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies to optimize processes and eliminate waste.
Collaborate closely with Engineering team, contract manufacturers and external vendors to ensure seamless
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