ZipRecruiter
Sr or Principal Catheter Manufacturing Engineer
ZipRecruiter, San Jose, California, United States, 95199
The Senior Manufacturing Engineer will lead the design, implementation, and optimization of IVUS catheter manufacturing processes at a fast-paced startup aiming to scale up production. This role requires expertise in medical device manufacturing, ensuring high quality production, regulatory compliance, and operational efficiency. The candidate will collaborate with cross-functional teams to drive innovation, reduce costs, troubleshoot issues, and manage the complete product lifecycle.
Process Development and Optimization
Lead the development – 75% onsite at both HQ and catheter CM site – to refine catheter manufacturing processes ensuring IPC-610 standard adherence, transducer acoustic testing, rigorous cleanliness and contamination controls, and scalable, cost-efficient production. Responsibilities
Process Development and Optimization:
Lead the on-site development and refinement of catheter manufacturing processes to ensure IPC-610 standard adherence, transducer acoustic testing, cleanliness, contamination controls, and scalable, cost-efficient production. Equipment and Tooling:
Specify, procure, and validate manufacturing equipment, tooling, and fixtures for production lines, focusing on precision and reliability. Quality Assurance:
Develop and maintain quality control systems, including process validation, risk management (FMEAs), CAPA, and root cause analysis, in compliance with FDA and ISO 13485 standards. Continuous Improvement:
Lead Lean Six Sigma initiatives to reduce waste, improve yield, and enhance production efficiency while maintaining product safety and performance. Cross-Functional Collaboration:
Work with R&D, supply chain, and regulatory teams to support product development, design transfer, and supplier qualification. Documentation and Compliance:
Create and maintain SOPs, MPIs, IHRs, BOMs, DMRs, and process flow diagrams, ensuring adherence to GMP and regulatory requirements. Troubleshooting and Problem Solving:
Diagnose and resolve complex manufacturing issues related to materials, equipment, or processes to minimize downtime and meet production schedules. Project Management:
Lead engineering projects including NPI, capacity expansions, and technology transfers, delivering on time and within budget. Risk Management:
Ensure compliance with manufacturing-related regulatory requirements, including supplier management oversight. Training:
Mentor engineers and production staff, fostering a culture of technical excellence and continuous learning. Qualifications
Education:
Bachelor's degree in Mechanical, Biomedical, or Manufacturing Engineering; Master's preferred. Experience:
At least 7 years in medical device manufacturing with diagnostic ultrasound or catheter products; experience with process development, validation, and optimization for Class II or III devices; experience with Lean Six Sigma; commercial or product launch experience is a plus. Technical Skills:
Expertise in CM processes for medical devices, proficiency in Minitab, Python, vision systems; knowledge of materials used in ultrasound and catheter products; familiarity with ISO 13485 & ISO 14971; understanding of NPI, DFM, DFA principles. Soft Skills:
Excellent problem-solving, analytical skills, and data-driven approach; strong communication and leadership abilities; capable of managing multiple high-priority projects; innovative mindset for integrating new manufacturing technologies.
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Lead the development – 75% onsite at both HQ and catheter CM site – to refine catheter manufacturing processes ensuring IPC-610 standard adherence, transducer acoustic testing, rigorous cleanliness and contamination controls, and scalable, cost-efficient production. Responsibilities
Process Development and Optimization:
Lead the on-site development and refinement of catheter manufacturing processes to ensure IPC-610 standard adherence, transducer acoustic testing, cleanliness, contamination controls, and scalable, cost-efficient production. Equipment and Tooling:
Specify, procure, and validate manufacturing equipment, tooling, and fixtures for production lines, focusing on precision and reliability. Quality Assurance:
Develop and maintain quality control systems, including process validation, risk management (FMEAs), CAPA, and root cause analysis, in compliance with FDA and ISO 13485 standards. Continuous Improvement:
Lead Lean Six Sigma initiatives to reduce waste, improve yield, and enhance production efficiency while maintaining product safety and performance. Cross-Functional Collaboration:
Work with R&D, supply chain, and regulatory teams to support product development, design transfer, and supplier qualification. Documentation and Compliance:
Create and maintain SOPs, MPIs, IHRs, BOMs, DMRs, and process flow diagrams, ensuring adherence to GMP and regulatory requirements. Troubleshooting and Problem Solving:
Diagnose and resolve complex manufacturing issues related to materials, equipment, or processes to minimize downtime and meet production schedules. Project Management:
Lead engineering projects including NPI, capacity expansions, and technology transfers, delivering on time and within budget. Risk Management:
Ensure compliance with manufacturing-related regulatory requirements, including supplier management oversight. Training:
Mentor engineers and production staff, fostering a culture of technical excellence and continuous learning. Qualifications
Education:
Bachelor's degree in Mechanical, Biomedical, or Manufacturing Engineering; Master's preferred. Experience:
At least 7 years in medical device manufacturing with diagnostic ultrasound or catheter products; experience with process development, validation, and optimization for Class II or III devices; experience with Lean Six Sigma; commercial or product launch experience is a plus. Technical Skills:
Expertise in CM processes for medical devices, proficiency in Minitab, Python, vision systems; knowledge of materials used in ultrasound and catheter products; familiarity with ISO 13485 & ISO 14971; understanding of NPI, DFM, DFA principles. Soft Skills:
Excellent problem-solving, analytical skills, and data-driven approach; strong communication and leadership abilities; capable of managing multiple high-priority projects; innovative mindset for integrating new manufacturing technologies.
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