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PURPOSE OF JOB : Oversee the company’s manufacturing activities and staff. Develop and execute policies, practices and procedures for efficient production of high quality products that meet user needs and fulfill business objectives. The Director of Manufacturing will play a key leadership role in the success of CO and will have a unique opportunity to contribute to all aspects of the medical device development cycle in a high-energy, small company environment.
MAJOR DUTIES AND RESPONSIBILITIES :
Oversee services provided by outside contract manufacturers and OEM suppliers including vendor selection and price negotiation, transfer of design and process qualifications, and monitoring vendor capacity and performance
Hire, train, and manage manufacturing and operations staff, as necessary.
Develop policies, practices, and procedures to identify and resolve production problems.
Manage implementation of new processes, technologies, or tooling needed to manufacture company’s products.
Provide manufacturing engineering resources for new product development projects, to ensure that products are optimally designed for manufacturing.
Participate in facilities planning meetings that involve manufacturing issues.
Comply with and help enforce standard policies and procedures.
Maintain accurate and complete records of manufacturing activities.
Perform duties in compliance with the Quality System.
Support and ensure compliance with FDA, ISO, and company quality standards.
EDUCATION REQUIREMENTS : BS/MS in Mechanical Engineering or other related technical field.
EXPERIENCE REQUIREMENTS : Minimum ten years experience in medical device product manufacturing with 3-5 years management experience, including implementation of FDA CGMP, ISO 13485, and MDD regulations.
OTHER QUALIFICATIONS : Must have the ability to develop and implement operating procedures, manufacturing process instructions, process validations, and lot history records related to manufacturing. Familiarity with set-up and maintenance of production environments including controlled environment rooms and line lay-out. Working knowledge of statistical techniques. Experience with new product transfer, prototype fabrication, process development, process validations, supply chain, and logistics. |
