Position Summary: The Manufacturing Manager will oversee the manufacturing operations for our Class III medical devices, ensuring that all processes comply with regulatory standards and company policies. This role requires a strong leader with extensive experience in manufacturing, quality assurance, and process optimization in a regulated environment.

Key Responsibilities:

• Operational Leadership: Lead and manage all manufacturing activities, ensuring production goals are met while maintaining quality and efficiency.
• Compliance and Quality Assurance: Ensure all manufacturing processes comply with FDA regulations and ISO standards. Implement and maintain quality management systems (QMS) to meet compliance requirements.
• Process Improvement: Identify opportunities for process improvements and implement lean manufacturing principles to enhance productivity and reduce waste.
• Team Management: Supervise, mentor, and develop manufacturing staff, fostering a culture of continuous improvement and teamwork.
• Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Supply Chain, and Regulatory Affairs to ensure seamless product development and production.
• Production Planning: Develop and manage production schedules to meet customer demands and optimize resource allocation.
• Budget Management: Prepare and manage the manufacturing budget, ensuring cost-effectiveness while meeting production targets.
• Safety and Training: Promote a culture of safety in the workplace, ensuring all staff are trained on safety protocols and best practices.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related field; advanced degree preferred.
• Minimum of 8 years of experience in manufacturing, preferably in the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and other relevant industry standards.
• Proven track record of leading teams and driving process improvements.
• Excellent problem-solving skills and ability to make data-driven decisions.
• Strong communication and interpersonal skills.

What We Offer:

• Competitive salary and benefits package
• Opportunities for professional development and career growth
• A collaborative and innovative work environment