Medical Device Operations Manager

Overview:

We are seeking a highly motivated and results-oriented Medical Device Operations Manager to lead and optimize manufacturing processes for our cutting-edge medical implant and delivery system.
This key role will oversee all aspects of production, ensuring quality, efficiency, and compliance with regulatory standards.

Key Responsibilities:

• Production Oversight: Ensure the smooth and efficient manufacturing of the medical implant and delivery system, adhering to all required standards and specifications.
• Process Improvement: Lead the development and implementation of new and improved manufacturing processes, including laser welding, pouch sealing, gluing, and cleaning procedures. Conduct and document thorough process validations (IQ/OQ/PQ) to ensure consistency and quality.
• Team Leadership: Build and lead a high-performing manufacturing team, fostering a culture of continuous improvement and operational excellence. Provide clear direction, motivate team members, and delegate tasks effectively.
• Inventory Management: Implement and maintain effective inventory control practices to optimize stock levels and minimize waste. Develop strong relationships with suppliers to ensure timely delivery of materials.
• Quality Collaboration: Partner closely with the QA team to continuously improve product quality and optimize manufacturing processes. Address technical challenges proactively and contribute to system enhancements.

Requirements:

• Education: Bachelor of Science degree in Mechanical Engineering or Biomedical Engineering.
• Experience:
  • At least 5 years of experience in a medical device company, preferably in cardiovascular implants and delivery systems manufacturing.
  • Experience with aseptic medical device manufacturing is highly preferred.
• Skills:
  • Excellent organizational and planning skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
  • Strong leadership and team collaboration skills to motivate and guide a team towards shared goals.
  • Strong proficiency in English (reading, writing, and speaking). Russian language skills are a plus.
  • Excellent analytical and problem-solving skills, with a focus on continuous improvement.
  • Strong understanding of quality management principles and regulatory requirements (e.g., ISO 13485).
  • Ability to work independently and take initiative to solve problems.
  • Excellent communication skills, both written and verbal, to communicate effectively with team members, cross-functional teams, and senior management.