Production Manager

About the role

Cirtec Medical has been a leading outsourcing partner for complex medical devices since 1990. We specialize in comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Position Summary

This position is responsible for leading, directing, and optimizing day-to-day manufacturing operations within our high-tech medical device contract manufacturing facility as dictated by Cirtec's business needs. Operating under strict ISO 13485 and FDA regulations, this role oversees the production of cutting-edge thin-film and microelectronics products.

Key Responsibilities

• Ensure conformance to the Company's quality system in accordance with ISO 13485, company, and customer requirements.
• Maintain conformance to all other Company policies, procedures, and work instructions.
• Plan and schedule work assignments to meet customer commitments, including effective scheduling of overtime and paid time off.
• Determine ongoing employee resource requirements based on production schedules, customer commitments, and equipment capacity.
• Absorb safe employee work practices, hazardous material handling, and good housekeeping in compliance with company policy, 5-S standards, and Federal/State regulations.
• Use company ERP, MES, and related business systems to monitor shop floor transactions for completeness, correctness, and compliance.
• Led cross-functional meetings and share production plans, results, and support requirements from other departments.
• Interview, recommend, and select candidates for employment.
• Identify and provide training and development in verified software systems as required to ensure a competent workforce.
• Demonstrate a high level of professionalism, competence, and communication to effectively lead tours of the production floor for management, customers, etc.
• Manage and evaluate employee performance, motivate, coach, counsel, and discipline employees to ensure maximum organizational effectiveness and accountability to world-class GMPs.
• Coordinate with product development and manufacturing transfer project teams to provide guidance on design for manufacturability, process development, and product launches.
• Communicate effectively with all functional managers.
• Take a leadership role in continuous improvement activities.
• Promote the culture of Lean Manufacturing, Six Sigma, 5-S, and Teamwork.
• Support Quality during FDA, ISO 13485, and customer audits by managing and providing compliant QMS documentation.
• Meet Safety, Quality, Delivery, and Cost deliverables in a timely manner.

Essential Skills

• Bachelor's Degree required.
• 1-3 years of experience in a management position.
• 5-10 years of experience in an ISO 13485 medical device manufacturing environment or similarly regulated environment.
• Demonstrated initiative and track record of improving manufacturing processes.
• Proficient in Microsoft Office and manufacturing business systems such as ERP, Training Software, and MES.
• Ability to understand and assist in production scheduling/forecasting.
• Must be able to read, write, and speak fluent English.
• Excellent organizational skills and strong communication skills.
• Ability to work independently.

Good to Have

• 3-5 years of experience working in a lean manufacturing environment, lean certification preferred.

Pay

$90,000 to $130,000 based on skills and experience.