Senior Manufacturing Engineer
Position Summary
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 will
collaborate with cross-functional teams to drive innovation, reduce cost, troubleshoot
issues, and manage the complete product lifecycle.
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 abilities 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