The Senior Manufacturing Engineer will lead the design, implementation, and optimization of IVUS catheter manufacturing processes at a fast-paced startup that is aiming to scale up production. This role requires expertise in medical device manufacturing, ensuring high quality production, regulatory compliance, and operational efficiency. The candidate willcollaborate with cross-functional teams to drive innovation, reduce cost, 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 to ensure 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, rigorous cleanliness and contamination controls, and scalable cost-efficient production. • Equipment and Tooling: Specify, procure, and validate manufacturing equipment, tooling, and fixtures for production lines, with a focus on precision and reliability. • Quality Assurance: Develop and maintain robust 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 closely with R&D, supply chain, and regulatory teams to support product development, design transfer to manufacturing, and supplier qualification. • Documentation and Compliance: Create and maintain comprehensive documentation - including 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 ensure production schedules are met. • Project Management: Lead engineering projects, including new product introductions (NPI), capacity expansions, and technology transfers, delivering on time and within budget. • Risk Management: Ensure compliance with all manufacturing-related regulatory requirements, including oversight of supplier management. • Training: Mentor engineers and production staff, fostering a culture of technical excellence and continuous learning. Qualifications • Education: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field. Master's degree preferred. • Experience: o Minimum of 7 years of experience in medical device manufacturing engineering with diagnostic ultrasound or catheter products preferred. o Experience with process development, validation, and optimization for Class II or III medical devices. Commercial or product launch experience is a plus o Experience with Lean Six Sigma methodologies. • Technical Skills: o Expertise in CM processes for medical devices, including precision assembly, sterilization, packaging and in-house manufacturing o Proficiency in Minitab, Python, vision systems o Strong working knowledge of materials used in ultrasound and catheter products (e.g., polymers, metals, adhesives) o Familiarity with regulatory standards (e.g., ISO 13485 & ISO 14971) o Familiarity with NPI, DFM and DFA principles • Soft Skills: o Excellent problem-solving and analytical skills, with a data-driven approach. o Strong communication and leadership bilities to collaborate across teams and mentor others. o Demonstrated capacity to manage multiple high-priority projects in dynamic environments while consistently meeting deadlines. o Ability to drive innovation by integrating emerging manufacturing technologies with a focus on continuous process optimization