Our client, an emerging leader in the field of in vitro diagnostics, has an immediate opening for an Instrument Manufacturing Manager. This role will manage instrument production planning and execution in compliance with the FDA Quality System Regulation (QSR) and ISO 13485.

Responsibilities:

• Contribute to the planning and execution of scaling instrument manufacturing operations, including part spares for Field Service
• Manage day to day assignments of the instrument manufacturing technicians to ensure timely execution of the production plan. Maintain build schedules to meet internal and external demand, including creation and closure of WO’s in ERP
• Set and manage performance targets for direct reports
• Regularly review paper based Device History Records (DHR) before product release
• Partner with Quality, Supply Chain, Logistics, Planning, and other operational team members to ensure all suppliers are held accountable for performance and continuous improvement - including product quality, lead time reduction, delivery, flexibility, inventory reduction, and cost reduction
• Partner with R&D, Engineering, Field Service, Marketing/Sales, Finance, and other departments to ensure that products, processes, plans, and requirements are translated into manufacturing operational plans
• Foster a positive work environment, recognize and reward team members for producing high quality products “on time”
• Implement risk management, continuous improvement, business continuity, and disaster recovery programs in partnership with other operational leaders
• Proactively identify and communicate areas of risk; seek assistance and input from senior operational leaders when developing and implementing risk mitigation initiatives
• Ensure environmental, health, and safety procedures are followed and maintain a frequent presence on the manufacturing floor, including regular “stand-up” meetings with the team
• Other responsibilities as required

Requirements:

• Bachelor’s degree in an engineering discipline strongly preferred. Must display a technical aptitude
• 5+ years of electromechanical manufacturing management experience in an FDA regulated environment required, IVD experience strongly preferred
• Experience in attracting, building, developing, and managing high performing manufacturing teams
• Ability to partner and communicate effectively across the organization to achieve production goals and maximize efficiency
• Must demonstrate sense of ownership and accountability and work with a results-oriented approach and a sense of urgency
• Must enjoy managing multiple competing priorities and approach tasks with a can-do and positive attitude
• Knowledge of current Good Manufacturing Practices (cGMP), the IVD Directive, the Medical Device Directive, ISO, and other relevant international and FDA regulations preferred
• Proven ability to execute using critical thinking in a fast paced, rapidly growing environment
• Experience with lean manufacturing, plant operations, and engineering
• Good financial skills in budgeting, expense control, and forecasting
• Hands-on experience using ERP systems required, familiarity with Oracle Fusion strongly preferred
• Must be able to lift up to 50 lbs.