Manufacturing Operations Manager
3 days ago
We are seeking a highly skilled Manufacturing Manager to lead our production operations at ClearPath Medical. As a key member of our team, you will be responsible for ensuring the precise manufacturing of medical devices, adhering to quality standards, and optimizing production efficiency.
Key Responsibilities- Leadership & Team Management: Oversee a team of manufacturing professionals, fostering a culture of excellence, continuous improvement, and compliance with safety protocols.
- Mentorship & Development: Mentor and develop team members, ensuring they are trained in the latest manufacturing techniques, particularly injection and overmolding.
- Production Scheduling: Manage the production schedule, ensuring timely delivery of medical devices while maintaining quality standards.
- Process Optimization: Implement and monitor production targets, focusing on resource optimization, including personnel, materials, and equipment.
- Quality Control: Ensure all products comply with regulatory requirements (FDA, ISO, and internal quality benchmarks).
- Process Improvement: Lead initiatives for process optimization, focusing on injection molding and overmolding techniques to enhance efficiency, reduce waste, and lower costs.
- Root Cause Analysis: Engage in root cause analysis and corrective action processes to improve manufacturing workflows.
- Regulatory Compliance: Ensure all manufacturing processes adhere to local, state, and federal regulations and company policies.
- Health & Safety: Promote and enforce health and safety practices to maintain a safe working environment.
- Industry Knowledge: Stay informed about advancements in injection molding technologies, particularly two-shot molding, insert molding, and overmolding, to stay on the cutting edge.
- Equipment Maintenance: Oversee the maintenance, upgrade, and integration of new manufacturing equipment.
- Reporting & Documentation: Generate regular reports on production metrics, quality issues, and operational efficiency. Maintain detailed documentation for compliance, traceability, and process improvement.
- Education: Bachelor's degree in Engineering, Manufacturing, Business Administration, or a related field; an advanced degree is a plus.
- Expertise: Specific expertise in injection molding and overmolding processes, preferably in the medical device industry.
- Knowledge: Profound knowledge of GMP (Good Manufacturing Practices), ISO standards for medical devices, and FDA regulations.
- Leadership: Proven leadership skills with the ability to manage, develop, and motivate a diverse team.
- Problem-Solving: Strong problem-solving skills with experience in process improvement methodologies.
- Communication: Excellent communication and interpersonal skills, capable of interfacing with all levels of the organization.
- 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 & 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: Ability to innovate within the constraints of medical device manufacturing, particularly in enhancing product functionality through overmolding techniques.
- Competitive Salary: Competitive salary and comprehensive benefits package.
- Career Growth: Opportunity to work in a dynamic, innovative environment focused on healthcare advancement.
- Professional Development: Career growth opportunities within the company.
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.
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