Production Director

Description

JOB SUMMARY:

Responsible for implementing the vision and strategic goals for NWM production activities. The Production Director plans, organizes, and controls production to ensure that goods are produced efficiently, on time and complying with regulatory and quality system procedures. Directs production activities across all shifts and establish manufacturing priorities to maintain quality, cost, and customer service within a safe working environment. Responsible for leading a team of over 35 employees across 3 shifts and 6 major product lines.  

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Manufacturing and Supply Chain

• Direct and coordinate all production activities to ensure products are manufactured on schedule, meeting or exceeding safety, quality, and cost standards. Ensure compliance with company policies and address performance issues appropriately and promptly.
• Establish and monitor key performance indicators (KPIs) to measure and improve results.
• Participate in the evaluation and planning of new investments or modifications to production equipment, ensuring alignment with long-term company strategy.
• Lead the adoption of Lean tools, methodologies, and behaviors to improve operational efficiency and sustain a culture of continuous improvement.
• Develop and monitor raw material/ finished goods inventory positions with input from key stakeholders.
• Prepare departmental costs and variances regarding productivity, short and long-range planning, labor scheduling, product scheduling & raw materials.

Facility and EHS Management 

• Champion a culture of safety by ensuring adherence to EH&S regulations and proactively addressing potential hazards. 
• Oversee facilities and EH&S responsibilities to maintain, monitor, adapt, and expand facility’s needs.

Leadership and Resource Management

• Manage and strategize current and future resources based on availability, skillset, and department commitments.
• Select, develop, coach, and mentor current and future personnel needs.
• Monitor and develop metrics for performance management reviews.
• Develop goals to support short term and long-term company goals.
• Foster a Culture of Quality to ensure customer and regulatory requirements are primary drivers in business decisions.
• Develop staffing strategies to meet current and future department needs, providing training programs and professional development opportunities for team members.
• Foster a high-performance team culture through mentorship, performance management, and career development planning.

Strategic Leadership

• Work with adjacent departments to strategize and best position department relative to company short and long-term objectives. 
• Lend production expertise to pipeline projects to ensure successful launch and production.
• Propose design changes to engineering team during development and post-launch.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• Familiarity with LEAN practices and processes i.e. 6S / problem solving / process improvement / daily management/ Takt time / one-piece flow / standard work etc.
• Demonstrated cost savings/productivity projects required. Working knowledge of financial and budgetary experience.
• Knowledge of medical device design control process and strategic involvement throughout different phases.
• Strong SAP knowledge and understanding of ERP systems used for Procurement and Production. 
• Knowledge of COGs/ cost accounting concepts.
• In-depth understanding of medical device manufacturing techniques, methodologies, and philosophies.
• Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHW, especially pertaining to product development, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.

EDUCATION AND EXPERIENCE:

• Minimum 10 years of progressive leadership experience in manufacturing engineering and/or production with a minimum of 5+ years in the medical device/biotech/pharma industry.
• BS Degree in Mechanical/Chemical/ Industrial / or related Engineering or Health Science field.
• Experience in Medical Device industry or in a highly regulated manufacturing environment.
• Experience in supply chain, logistical, warehousing or distribution is desired.

PHYSICAL R