Manufacturing Operations Director

3 weeks ago

Orange, California, United States ClearPath Medical Full time

About the Role

ClearPath Medical is seeking a seasoned Manufacturing Manager to lead our production operations and drive innovation in medical device manufacturing.

About the Company

ClearPath Medical is a leading manufacturer of medical devices, committed to advancing healthcare through innovative, high-quality products. We prioritize stringent industry standards and patient care.

Job Summary

As a Manufacturing Manager, you will oversee our production operations, ensuring medical devices are manufactured precisely, adhering to quality standards, and optimizing production efficiency. This role involves leading a team of manufacturing professionals, fostering a culture of excellence, continuous improvement, and compliance with safety protocols.

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, 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***

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