Production Manager (Medical Devices experience)

Vapotherm respiratory therapy medical devices

The ideal candidate must have at least 5 years of experience leading production teams in regulated manufacturing environments, preferably within the medical device industry.

The role requires bilingual proficiency in English and Spanish (B2+), strong experience in production planning, ERP systems, Lean Manufacturing, continuous improvement, KPI management, and budget administration. Candidates should also have a proven track record in team leadership, employee development, and compliance with ISO 13485 and FDA/QSR requirements, including participation in regulatory audits.

Top 5 Responsibilities

• Lead production operations and manage teams of assemblers and supervisors to achieve production plans and quality objectives.
• Develop and execute quarterly, monthly, weekly, and daily production plans in alignment with Supply Chain requirements.
• Monitor and drive key operational metrics, including build plan adherence, first-pass yield, operator efficiency, uptime, ERP transaction accuracy, and scrap reduction.
• Ensure compliance with ISO 13485, FDA/QSR regulations, safety requirements, and quality system standards while representing Production during audits.
• Manage departmental budgets, support continuous improvement initiatives, and lead production-related activities for New Product Introductions (NPI).