Qualifications

• 12+ years of experience in the medical device industry.
• Expertise in design control and design transfer processes.
• Proven track record of leading complex electromechanical medical device transfers.
• Experience in pilot manufacturing and ensuring manufacturing readiness.
• Skilled in product development and manufacturing engineering.
• Proficient in manufacturing process development and optimization.
• Knowledgeable in FDA regulations, ISO 13485, and design control.

Responsibilities

• Lead design transfer and design control initiatives for medical devices.
• Bridge collaboration between R&D, systems, mechanical, manufacturing, and quality teams.
• Develop and optimize manufacturing processes and assembly methods for production scaling.
• Build and troubleshoot pilot units to ensure functionality and reliability.
• Identify and mitigate design, tooling, and assembly risks prior to production scale-up.
• Drive manufacturing readiness from prototype through pilot to high-volume production.
• Create and maintain documentation including DMRs, work instructions, and assembly procedures.

Benefits

• Opportunity to work with advanced medical devices and cutting-edge technology.
• Collaborative environment bridging various engineering disciplines.
• Influence key decisions in technical leading and design transfer.
• Engagement in high-impact projects transitioning from R&D to commercialization.