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Lead Manufacturing Engineer II
2 months ago
As a Lead Manufacturing Engineer II, you will play a pivotal role in advancing the operational goals of our production team, focusing on the development of medical products utilized in healthcare applications.
Your responsibilities will encompass supporting various manufacturing sectors, including Ceramics, Collagen, Polymer, Mechanical Devices, Polyurethanes, and Silicon Hydrogel technologies, all within our specialized clean room environments.
In your capacity as the process owner, you will be instrumental in driving daily performance metrics, enhancing safety protocols, improving yield rates, upgrading processes and equipment, and spearheading cost reduction initiatives.
Key Responsibilities:• Develop and oversee process-centered metrics to facilitate continuous improvement.
• Address and resolve process and equipment challenges to ensure seamless product flow.
• Champion safety, health, and environmental initiatives, positively influencing the operational performance through proactive engagement.
• Draft, validate, and implement IQ, OQ, POQ, PQ, and process characterization documentation.
• Conduct design of experiments (DOE) aimed at process optimization, documenting findings in technical reports.
• Identify and capitalize on significant improvement opportunities (e.g., yield enhancement, equipment optimization, cost efficiency), securing necessary resources and executing solutions effectively.
• Lead both immediate (NCR) and strategic (complaints and CAPA) initiatives to enhance product quality.
• Collaborate with cross-functional teams, providing technical guidance on various operational challenges.
• Mentor junior engineers and interns, fostering their professional development within their designated areas.
You Bring:• A Bachelor of Science degree in Mechanical, Chemical, or Industrial Engineering, or a related field with relevant experience.
• A minimum of 8 years of practical experience in a dynamic manufacturing setting, ideally within the medical equipment or device sector.
• Proven expertise in designing, constructing, and maintaining small tools and fixtures using CAD software such as Creo.
• A track record of generating innovative ideas, securing business support, and successfully implementing solutions.
• Experience working in a regulated environment, with a preference for the medical device industry, including familiarity with ISO 13485 and 21CFR820 standards.
• Strong project management skills, capable of balancing multiple initiatives alongside routine responsibilities.
• Proficient in using MiniTab software for process capability analysis, DOE, and control chart interpretation.
