Director of Manufacturing Operations

TITLE:  Director of Manufacturing Operations

DIRECT REPORTS:  Facilities Maintenance Technician

REPORTS TO: VP of Engineering

POSITION SUMMARY

The Director of Manufacturing Operations will be responsible for overseeing procurement, fulfillment, raw material & finished goods inventory, production planning, and daily manufacturing operations. This includes managing production, ensuring quality standards, and optimizing efficiency. The ideal candidate will have a strong background in supply chain management, with the ability to integrate and oversee the entire supply chain process, from procurement to distribution.

ESSENTIAL JOB FUNCTIONS

·      Oversee day-to-day manufacturing operations, ensuring production schedules are met

·      Implement and maintain efficient manufacturing processes and workflows

·      Set clear performance goals and expectations for site manufacturing. Monitor and analyze production metrics and KPIs to ensure goals are met or exceeded and drive transformational improvements on a regular basis

·      Ensure that all manufacturing activities adhere to regulatory, safety and quality standards, consistently championing this culture within the organization.

·      Collaborate with cross-functional partners in support of new product development efforts required to integrate new technologies

·      Provide input to and implement operational and financial goals and objectives for the manufacturing area assigned. Track and trend performance levels and maximize operations.

·      Recommend and implement ideas to reduce costs, adapt and transform the organization to meet changing business needs

·      Assist teams in troubleshooting manufacturing issues. Ensure staff is provided technical knowledge and training to efficiently produce the highest quality products

·      Collaborate with peers and cross-functional partners such as Engineering and Quality to ensure seamless operations and quality improvements. Synthesize action plans, timelines and budgets to meet project and product goals

·      Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations

·      Responsible for completing established goals, prioritizing project work and controlling and coordinating all activities and improvement efforts across manufacturing areas

·      Optimize inventory levels to meet production demands while minimizing carrying costs

·      Coordinate with logistics to ensure efficient and timely delivery of finished goods to customers

·      Foster a culture of continuous improvement and accountability

·      Identify opportunities for process improvements and implement Lean Manufacturing and Six Sigma principles

·      Drive initiatives to reduce waste, increase efficiency, and improve product quality

·      Develop and manage the manufacturing budget, ensuring cost-effective operations

·      Monitor expenses and implement cost-saving measures without compromising quality or safety

·      Ensure all products meet quality standards, product requirements and customer specifications

·      Implement and maintain quality control processes and procedures

·      Knowledge of best practices in regulated diagnostics production environments

·      Technology implementation and knowledge of the latest manufacturing technologies and automation systems to enhance productivity, quality and scalability

·      Effective and timely communication to leadership regarding manufacturing progress, blockers, and proposed solutions

·      Ability to establish/demonstrate manufacturing process/equipment capabilities and drive manufacturing development for new product development

·      Establish, manage, and complete design transfer activities for new product development

·      Manage the Master Validation Plan for manufacturing

·      Manage equipment calibration and preventive maintenance schedules

SKILLS AND ABILITIES

·      Strategic planning to develop and execute growth strategies that align manufacturing operations with business objectives and new product introductions

·      Risk management to identify and mitigate risks associated with scaling operations

·      Proven experience in supply chain management, including procurement, inventory management, and logistics

·      Strong knowledge of Lean Manufacturing, Six Sigma, and other process improvement methodologies

·      Strong working knowledge of industry regulations and legal guidelines (e.g., FDA 21 CFR Part 820, ISO 13485 and ISO 14971, GMP, GDP, GLP etc.)

·      Excellent leadership and team management skills with the ability to develop professional growth for the team

·      Strong analytical and problem-solving abilities to interpret production data and trends then model future scenarios

·      Proficiency in Oracle NetSuite ERP software

·      Excellent organization, collaboration, communication and interpersonal skills for both internal cross functional and external stakeholder engagement

·      Excellent attention to detail

·      Familiarity with Lyopholization processes

·      Familiarity with Medical Device Production

·      Familiarity with Medical Device Consumable Production

MINIMUM REQUIREMENTS

·      Bachelor’s degree in engineering, Manufacturing, Supply Chain Management, or a related field

·      10 years of experience managing manufacturing operations within a regulated environment such as complex medical devices, IVD consumables, electronics instrumentation, and/or pharmaceuticals

PREFERRED REQUIREMENTS

·      IVD/complex medical device experience strongly preferred

·      Experience managing manufacturing operations for products with large amount of custom components

·      Experience with automated and semi-automated manufacturing equipment

·      Master’s degree in related field