Overall goal of the position:

Oversee all aspects of the manufacturing process for Class II and Class III medical devices and products.

Specific Tasks:

• Develop and implement manufacturing strategies, plans, and objectives to meet production goals.
• Create and maintain production schedules, ensuring optimal resource allocation and efficient production flow.
• Communicate with suppliers and vendors, in partnership with project teams and materials coordinator, to manage the procurement of raw materials and components.
• Monitor and analyze production data to identify areas for improvement and implement corrective actions when necessary.
• Establish and enforce quality control standards and procedures to ensure compliance with regulations and industry standards.
• Collaborate with the Quality Assurance team to conduct product inspections and address any quality issues or non-compliance.
• Continuously monitor and improve manufacturing processes to enhance quality and reduce defects and errors.
• Stay updated on relevant regulatory guidelines and ensure compliance with relevant regulations and standards (e.g., FDA, ISO).
• Collaborate with Quality Assurance team to ensure timely submission of required documentation and adherence to regulatory requirements.
• Address any compliance issues promptly and effectively to maintain certification and regulatory approvals.
• Hire, train, and lead a team of manufacturing personnel, ensuring appropriate skills and knowledge are in place.
• Set performance goals, provide regular feedback, and conduct regular development and coaching conversations with individuals.
• Foster a positive and safe work environment, promoting teamwork, collaboration, and continuous improvement.
• Coordinate with cross-functional teams (engineering, accounts management, quality assurance) to ensure smooth product development and transfer to manufacturing.
• Collaborate with accounts manager and project coordinators to ensure production capabilities align with customer demands.
• Additional responsibilities as defined by the Executive Leadership.

Your background:

• BA/BS in engineering, manufacturing, or a related field.
• Proven experience in medical device manufacturing, with at least 2 years in a managerial or leadership role.
• Strong knowledge of manufacturing processes, quality control systems, and regulatory requirements (e.g., FDA ISO).
• Excellent leadership and interpersonal skills, with the ability to motivate and manage a diverse team.
• Analytical and problem-solving skills, able to identify and address operational issues effectively.
• Strong organizational skills, ability to prioritize tasks, and meet deadlines.
• Familiarity with lean manufacturing principles and continuous improvement methodologies is a plus.
• Experience working with manufacturing-based technology processes and principles preferred.
• Sound written and oral communication skills; must be able to write and understand routine reports, follow oral and written instructions, and speak effectively with management, customers, and technical staff audiences.
• Must have knowledge of use and operation of standard office equipment and be familiar with commonly used email, Internet, word processing, databases, and spreadsheets.

Compensation:

• $100,900 to $145,300 annually, depending upon qualifications
• Paid vacation and sick leave; paid holidays
• Partial payment by company of Group Health Insurance
• 401(K) retirement plan with limited company matching