Job Summary:

As the Senior Manufacturing Engineer, you will play a critical role in leading the successful transition of our cutting-edge biomedical device from research and development to large-scale manufacturing. Collaborating with cross-functional teams, you will be responsible for developing and optimizing manufacturing processes, ensuring adherence to regulatory standards, and maintaining the highest quality throughout the production phase. Your expertise will be instrumental in establishing efficient and reliable manufacturing practices, enabling us to provide innovative healthcare solutions to millions of individuals worldwide.

Duties & Responsibilities

· Process Development: Take the lead in developing and optimizing the manufacturing processes for our state-of-the-art biomedical device. Collaborate with R&D, engineering, and production teams to transform research findings into scalable and efficient production methods.

· Quality Assurance: Establish and implement robust quality control protocols to ensure the accuracy and reliability of the device during production. Continuously monitor and improve product quality through statistical analysis and root cause investigation.

· Regulatory Compliance: Ensure compliance with all relevant regulatory standards and requirements for medical devices during the manufacturing process. Collaborate with regulatory affairs to obtain necessary certifications and approvals.

· Supplier Management: Evaluate and select reliable suppliers for critical components and materials. Build strong relationships with suppliers to ensure a stable supply chain.

· Scalability Planning: Develop strategies for scaling up the manufacturing process to meet increasing demand while maintaining stringent quality standards to processes for high volume production and implementing automated processes.

· Documentation and Standardization: Create comprehensive and standardized manufacturing process documentation. Ensure adherence to protocols and procedures to achieve consistency in production.

· Personnel Training: Provide comprehensive training and mentorship to production personnel on the manufacturing process, quality control procedures, and safety guidelines.

· Pilot Production Run: Oversee a pilot production run to identify and address any potential challenges or improvements before full-scale manufacturing.

· Continuous Improvement: Continuously seek opportunities to enhance the manufacturing process, product quality, and production efficiency based on user feedback and industry best practices.

· Environmental and Safety Considerations: Implement sustainable practices in the manufacturing process and prioritize safety measures for employees and product users.

Minimum Qualifications and Experience:

• Master’s degree in Biomedical Engineering, Industrial Engineering, Mechanical Engineering, Chemical Engineering, or related fields.
• 5+ years of relevant industrial experience with an emphasis on medical device manufacturing, manufacturing automation, and related manufacturing equipment design, operation, maintenance, repair, etc.
• Experience in taking a major device from development to customer shipment.
• Experience working with sterile operations and material selection.
• Knowledge of Medical Device sterilization processes.
• Strong knowledge of regulatory requirements for medical devices and experience in obtaining certifications and approvals, specifically working knowledge of FDA 510(k) approval process, ISO standards, GMP regulations & IEC 60601.
• Proven experience in process optimization, quality control, and supply chain management.
• Proficient in using statistical analysis tools and methodologies for quality improvement.
• Excellent communication and leadership skills, with a track record of successfully leading cross-functional teams.
• Strong problem-solving abilities and a data-driven approach to decision-making.
• Ability to thrive in a fast-paced and dynamic environment.

Physical requirements/Work Environment

This position primarily works in a laboratory environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May require standing for extended periods when conducting experiments, meetings, walking in the facilities. Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.