Manufacturing Process Development Leader
3 weeks ago
We are seeking an experienced Manufacturing Process Development Leader to join our team at Shockwave Medical. As a key member of our R&D group, you will play a crucial role in designing, developing, and implementing processes, tooling, and fixtures for our medical devices.
Key Responsibilities:
• Design and develop processes, tooling, and fixtures for medical devices, collaborating with R&D, Quality, and Production departments.
• Analyze process performance and capabilities for company products, identifying areas for improvement.
• Perform tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing, ensuring compliance with quality standards.
• Develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, reducing the risk of defects and improving overall quality.
• Participate in development and maintenance of product design FMEAs, working closely with cross-functional teams to ensure seamless integration.
• Identify requirements, advise Operations management, prepare proposals, and implement equipment & fixturing needed for development and manufacturing efforts, driving business growth and efficiency.
• Develop and maintain documentation for design control, product configurations, and other Quality System requirements, ensuring regulatory compliance and maintaining high-quality standards.
• Lead and/or actively participate in product/process engineering problem resolution, leveraging your expertise to resolve complex issues and drive results.
• Lead and/or actively participate in process/product improvement projects, Validation activities (IQ, OQ, and PQ), and other initiatives that drive business growth and improve quality.
• Collaborate with Materials, QA, and R&D departments to select suppliers, develop technical specifications, and ensure compliance with quality standards.
• Conduct complex engineering studies and investigations, preparing reports for company leadership and driving informed decision-making.
• Provide engineering guidance to other departments, help to train new engineers, and stay up-to-date on industry trends and best practices.
• Perform productivity and costing analyses, identifying opportunities to reduce costs and improve efficiency while maintaining high-quality standards.
Requirements:
• Bachelor's degree in an Engineering discipline (Mechanical, Biomedical, etc.).
• Minimum of 10 years of experience in medical device manufacturing with a BS or 8 years with an MS or PhD degree.
• Experience with process validations (IQ-OQ-PQ), Lean Sigma, 6S, and statistical analysis tools (e.g., CPK, DOE).
• Strong written and verbal communication skills, with the ability to create and deliver presentations.
• Advanced skills in software applications such as Microsoft Office and Solidworks.
• Expertise in data analysis, problem-solving, and design thinking.
• Knowledge of Quality System requirements (e.g., QSRs, ISO, MDD) and the ability to work in a fast-paced environment managing multiple priorities.
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