Manufacturing Lead

About the Company

Remedy Robotics is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care.

Responsibilities

• Lead manufacturing engineering from prototype through production for disposable instruments and surgical robotic systems
• Drive design transfer, DFM/DFA, supplier qualification, and production process development
• Execute manufacturing validation activities (IQ/OQ/PQ) and maintain documentation required under ISO 13485
• Define and improve manufacturing KPIs including yield, cost, lead time, and defect rates
• Build and scale the manufacturing and operations team as the product matures

Requirements

• 8+ years of hands-on experience in manufacturing engineering and operations leadership in the medical device industry
• Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field
• Proven experience leading Class II and/or Class III medical devices from R&D through production
• Expertise in design transfer, process validation (IQ/OQ/PQ), and ISO 13485 compliance
• Success managing contract manufacturers and component suppliers in startup environments

Preferred Qualifications

• Experience manufacturing disposable medical devices, injection molding, and sterile barrier packaging
• Experience with EO or gamma sterilization validation
• Experience developing or scaling catheter or guidewire assembly processes
• Experience with electromechanical or capital equipment manufacturing
• Experience supporting FDA inspections, audits, or regulatory compliance
• Background in Lean Manufacturing or Six Sigma methodologies