Manufacturing Manager Job at ClearPath Medical in Orange

About the company:

ClearPath Medical is at the forefront of medical device manufacturing and is committed to advancing healthcare through innovative, high-quality products. We are dedicated to producing medical devices that meet stringent industry standards and enhance patient care.

Job Summary:

ClearPath Medical seeks a Manufacturing Manager with a deep understanding of injection molding and overmolding processes. This role involves leading our production operations, ensuring that medical devices are manufactured precisely, adhering to quality standards, and optimizing production efficiency. It is an excellent opportunity for someone looking to advance.

Key Responsibilities:

• Leadership & Team Management:

• Oversee a team of manufacturing professionals, fostering a culture of excellence, continuous improvement, and compliance with safety protocols.

• Mentor and develop team members, ensuring they are trained in the latest manufacturing techniques, particularly injection and overmolding.

• Manage the production schedule, ensuring 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, including managing quality systems within the manufacturing environment.

• Lead initiatives for process optimization, focusing on injection molding and overmolding techniques to enhance efficiency, reduce waste, and lower costs.

• 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, particularly two-shot molding, insert molding, and overmolding, to stay on the cutting edge.

• Oversee the maintenance, upgrade, and integration of new manufacturing equipment.

• Generate regular reports on production metrics, quality issues, and operational efficiency.

• Maintain detailed documentation for compliance, traceability, and process improvement.

Qualifications:

• Bachelor's degree in Engineering, Manufacturing, Business Administration, or a related field; 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.

Additional Requirements for Injection/Overmolding:

Material Knowledge: Deep understanding of materials used in injection molding for medical devices, including thermoplastic polyurethane (TPU), thermoplastic elastomers (TPE), silicone (LSR), and their properties in overmolding applications.

Process Expertise: Proficient in both traditional injection molding and advanced techniques like two-shot molding, insert molding, and overmolding, understanding the nuances of each process for medical device manufacturing.

Quality and Compliance: Experience in ensuring that overmolded components meet medical grade standards, understanding the implications of material shrinkage, mold design, and process parameters on final product quality.

Innovation in Manufacturing: Ability to innovate within the constraints of medical device manufacturing, particularly in enhancing product functionality through overmolding techniques.

We Offer:

• Competitive salary and comprehensive benefits package.
• Opportunity to work in a dynamic, innovative environment focused on healthcare advancement.
• Career growth opportunities within the company.

How to Apply:

Please submit your resume and a cover letter explaining why you are the perfect fit for this role.

ClearPath Medical is an Equal Opportunity Employer and encourages candidates of all backgrounds to apply.

***Candidate Inquiries Only-No Third-Parties***