The Director of Operations (DO) is responsible for setting the operational strategy to meet manufacturing and fulfillment demands at OnPoint Surgical, Inc. This is the opportunity for a strategic and hands-on leader to own Production operations in a dynamic, entrepreneurial environment. You will be responsible for the setup and expansion of the manufacturing process and infrastructure. Once established you will be responsible for monitoring and managing Safety, Quality, Delivery and Inventory of the Operations. Responsibilities include contract manufacturing, quality control, supply chain management, logistics, contractor inventory management, service and support, delivery of product, and general management of company operations. Reporting to the company’s CFO, the Director of Operations is critical in developing and implementing strategies to optimize production efficiency, reduce costs, improve product quality, manage relationships with contract manufacturers, and ensure compliance with the FDA and ISO. In addition, this role will ensure customer satisfaction by managing key relationships throughout the service and support lifecycle, building the infrastructure required for success.
Duties and Responsibilities:
- Responsible for fulfillment of sales orders.
- Coordinate with sales and finance forecasting and inventory.
- Responsible for the setup of the company’s manufacturing process and infrastructure.
- Lead production planning and scaling of contract manufacturing operations to meet demand.
- Manage contract manufacturers and logistics to ensure products are at the right inventory levels to meet sales forecasting of products and strive for improved turns in support of optimizing working capital for the business.
- Guide team on systematic approaches to identify, prioritize, communicate, and resolve third party manufacturing, logistics and quality issues.
- Continually evaluate resource utilization (contract manufacturing, assembly / test equipment, workforce, and facility) and align capabilities and capacity with business needs.
- Develop the contract manufacturing and logistics plan and establish procedures for maintaining and improving of the manufacturing operations to ensure that products conform to established customers, company quality standards as well as profitability of operations.
- Support and ensure procedures and methods to ensure compliance with FDA, GMP, ISO, and QA/QC medical, state and local regulatory agencies.
- Direct and coordinate various programs essential to operational procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.).
- Perform miscellaneous duties and projects as assigned and required.
- Mentor and develop company talent as a direct manager and manager of managers.
- General knowledge of assembly and machining principles.
- Strong problem solver and creative thinker.
Required Skills and Qualifications:
- Bachelor’s degree in Engineering, Technology, Business, Manufacturing Management or equivalent.
- 10+ years of experience in manufacturing management, preferably in process-oriented operations, medical device and/or highly regulated industry.
- Demonstrated success managing manufacturing, cycle count and inventory goals.
- Proven track record of successfully leading and managing operations for fast growth, early-stage companies.
- Knowledge of industry regulations and quality standards (e.g., ISO 13485, FDA QSR).
- Experience managing budgets and financial performance.
- Experience managing relationships with contract manufacturers and optimizing inventory levels.
- Position will be based in Bedford, MA.