Resmed · Calabasas, CAPrepare for this interview
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*Please note the hours for this shift are Monday to Friday 1 PM-10 PM The Manufacturing Engineer (Liquid Silicone Rubber Molding) is a critical role responsible for supporting production lines and manufacturing processes for Liquid Silicone Rubber (LSR) molding operations. This position involves driving execution of molding technologies, improving efficiency, and ensuring compliance with global quality and regulatory standards in the medical device industry. The role will also include collaboration with cross-functional teams, vendors, and management to deliver high-quality products while achieving cost and productivity targets. Let's talk about Responsibilities Process Optimization: Validate robust manufacturing processes for LSR molding. Drive revalidation activities for process/tool/equipment changes in production Lead process improvement initiatives to enhance productivity, cycle time, and material utilization. Design experiments and analyze data to optimize process parameters, ensuring consistent product quality. Develop and implement control plans, process flow diagrams, and PFMEAs to mitigate risks. Project Management: Serve as the technical lead in root cause investigations and implementing countermeasures. Coordinate with vendors and suppliers for equipment selection, procurement, and commissioning. Provide regular updates to stakeholders, including management, on project status and milestones. Regulatory Compliance and Documentation: Ensure all processes meet ISO 13485 and FDA regulations for medical device manufacturing. Develop and maintain detailed documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs). Ensure compliance with electrical and regulatory requirements for North American and European markets. Collaboration and Cross-Functional Support: Partner with Quality, Manufacturing Engineering, and Production teams to resolve process challenges. Work with Design Engineering to provide feedback on part designs for manufacturability (DFM). Innovation and Continuous Improvement: Research and integrate emerging technologies in LSR molding to improve efficiency and reduce waste. Lead initiatives for automation, such as robotic part handling and lights-out manufacturing. Let's talk about Qualifications and Experience Required Qualifications: Bachelor's degree in mechanical engineering, Plastics Engineering, Manufacturing Engineering, or a related field. Minimum 3+ years of experience in Manufacturing Engineering (Ideally with Injection Molding/LSR Manufacturing). Experience supporting production lines in 24X7 environments. Hands-on experience with Molding machines and robotic automation Proven track record in leading and supporting engineering projects in highly collaborative environments Strong knowledge of quality systems (ISO 13485, FDA regulations) and validation protocols. Proficient in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Minitab, JMP).
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