Manufacturing Manager

Clearpath Medical • Orange, CA

393d • $60,000 - $100,000

About The Position

The Manufacturing Manager at ClearPath Medical is responsible for leading production operations in the medical device manufacturing sector, with a focus on injection molding and overmolding processes. This role emphasizes quality control, process improvement, and team management to ensure that medical devices are produced efficiently and meet stringent regulatory standards.

Requirements

• Bachelor's degree in Engineering, Manufacturing, or a related field preferred; an advanced degree is a plus.
• Specific expertise in injection molding and overmolding processes, preferably in the medical device industry.
• Profound knowledge of GMP (Good Manufacturing Practices), ISO standards for medical devices, and FDA regulations.
• Proven leadership skills with the ability to manage, develop, and motivate a diverse team.
• Strong problem-solving skills with experience in process improvement methodologies.
• Excellent communication and interpersonal skills, capable of interfacing with all levels of the organization.

Nice To Haves

• Deep understanding of materials used in injection molding for medical devices, including thermoplastic polyurethane (TPU), thermoplastic elastomers (TPE), and silicone (LSR).
• Proficient in both traditional injection molding and advanced techniques like two-shot molding, insert molding, and overmolding.
• Experience in ensuring that overmolded components meet medical grade standards.

Responsibilities

• Oversee a team of manufacturing professionals, fostering a culture of excellence and compliance with safety protocols.
• Manage the production schedule to ensure timely delivery of medical devices while maintaining quality standards.
• Implement and monitor production targets, focusing on resource optimization including personnel, materials, and equipment.
• Ensure all products comply with regulatory requirements (FDA, ISO 13485) and internal quality benchmarks.
• Oversee quality control processes and manage quality systems within the manufacturing environment.
• Lead initiatives for process optimization in injection molding and overmolding techniques to enhance efficiency and reduce waste.
• Engage in root cause analysis and corrective action processes to improve manufacturing workflows.
• Ensure all manufacturing processes adhere to local, state, and federal regulations and company policies.
• Promote and enforce health and safety practices to maintain a safe working environment.
• Stay informed about advancements in injection molding technologies and oversee the maintenance and upgrade of manufacturing equipment.
• Generate regular reports on production metrics, quality issues, and operational efficiency.
• Maintain detailed documentation for compliance, traceability, and process improvement.

Benefits

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree