General Manager – Production

About The Role

Vita Durare is establishing a state-of-the-art production facility for the manufacturing of cardiovascular medical devices and are seeking an experienced General Manager – Production to lead the setup and ongoing operations of the facility. This is a foundational leadership role, ideal for a driven professional with deep expertise in medical device manufacturing and a track record of building high-performing production environments from the ground up.

Key Responsibilities

• Lead the planning, setup, and commissioning of the production facility, including layout, equipment procurement coordination, and workflow design.
• Develop and implement manufacturing processes compliant with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards.
• Establish and maintain a Quality Management System (QMS) for cardiovascular device production.
• Drive production planning, scheduling, and capacity management to meet output targets.
• Oversee supply chain, vendor management, and raw material sourcing.
• Lead, recruit, and develop a cross-functional production team including engineers, technicians, and quality personnel.
• Monitor KPIs and drive continuous improvement initiatives using Lean, Six Sigma, or equivalent methodologies.
• Ensure full compliance with cleanroom protocols, GMP standards, and workplace safety regulations.
• Collaborate with R&D, regulatory affairs, and commercial teams to support product development and market readiness.
• Manage operational budgets, cost controls, and resource allocation.

Requirements

Experience & Education:

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or a related field (Master's preferred).
• 10+ years of experience in manufacturing operations, with at least 5 years in a senior leadership role within the medical device industry.
• Proven experience in cardiovascular, interventional, or Class II/III medical device manufacturing is strongly preferred.
• Experience setting up or scaling a greenfield manufacturing facility is a significant advantage.

Regulatory & Quality:

• Strong working knowledge of ISO 13485, FDA QSR (21 CFR Part 820), CE Marking, and MDR compliance.
• Familiarity with risk management frameworks (ISO 14971) and design controls.
• Experience leading regulatory audits and inspections.

Technical & Software Skills:

• Proficiency in ERP/MES systems — experience with Odoo is highly preferred.
• Familiarity with project management platforms such as Jira, Asana, or MS Project.
• Working knowledge of CAD/PLM tools (e.g., SolidWorks PDM, Autodesk Fusion, Arena PLM, or Windchill) is a plus.
• Data-driven mindset with experience using analytics dashboards and reporting tools.

Leadership & Soft Skills:

• Strong leadership and team-building capabilities with experience managing multidisciplinary teams.
• Excellent communication and stakeholder management skills.
• Strategic thinker with hands-on execution ability.
• High attention to detail with a quality-first mindset.

What We Offer

• A rare opportunity to build and shape a production facility from the ground up.
• A mission-driven environment focused on improving cardiovascular patient outcomes.
• Competitive compensation package.
• Medical Coverage [OPD & IPD]