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.