General Manager NItinol

. GM - Head of Nitinol Stent and Frame Manufacturing (Team Lead)

Job Title: GM - Nitinol Manufacturing
Department: R&D
Reports to: Global R&D Head

Job Responsibilities (JD):

• Lead and manage the setup of in-house nitinol stent and valve manufacturing processes.
• Supervise the technology transfer for processes like laser cutting, electropolishing, shape setting, heat treatment, and valve assembly.
• Oversee the procurement, installation, and validation of manufacturing equipment.
• Ensure regulatory compliance with ISO 13485, FDA 21 CFR 820, and other standards.
• Collaborate with R&D, Quality, and Engineering teams to align product design with manufacturing.
• Manage production schedules, workforce allocation, and operational efficiency.
• Drive process improvements, focusing on product quality, production efficiency, and cost reduction.

Roles & Responsibilities (R&R):

• Lead a cross-functional team consisting of engineers, operators, and technicians.
• Set key performance indicators (KPIs) for the production team.
• Monitor overall production performance, ensuring quality and timelines are met.
• Ensure all processes are documented and validated in compliance with regulatory requirements.
• Coordinate with external vendors and suppliers for materials and equipment.

Qualifications:

• Bachelors/Master’s degree in Mechanical Engineering, Materials Science, or a related field.
• 10+ years of experience in nitinol stent and valve manufacturing.
• Strong leadership, communication, and project management skills.