Job Description

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

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