Director of Manufacturing Engineering
San Diego, CA
This position is responsible for the implementation and production of the company’s vascular technology and technology transfer/validation to commercial operations. The role requires the oversight and management of production and facilities including: forecasting inventory material control, production control, production engineering, and manufacturing engineering.
Essential Job Functions
- Must demonstrate strategic and forward thinking to set and meet company goals. Must also demonstrate appropriate business judgment in all aspects of decision making which considers and supports the broader company objectives.
- Based on company requirements, defines production goals, implements and improves technologies and resolve problems in conjunctions with Quality Assurance, Product Development and Engineering.
- Provide solid leadership and manage staff by setting the standard of a strong, teamwork-focused work ethic.
- Collaborates with Engineering and Product Development to build a broad understanding of the product, process and design intent and implements manufacturing process to support the company’s biomaterial products and provides the manufacturing component for successful technology transfer to commercial scale operations.
- Develops, implement and validates processes that support the program(s) that will scale up production and validation of product.
- Develops and continuously improves, manufacturing and supply chain processes and systems, and identifies opportunities to improve organizational effectiveness and efficiency by optimizing workflow.
- Develops supplier base and effectively manages vendor relationships.
- Perform material and resource planning to meet the growing needs of the company.
- Organizes and manages facilities, including space planning, as required to support technical operations.
- Minimum BS Engineering degree required.
- 10+ years operations management experience preferred in an ISO 9001 and/or medical device manufacturing environment, or equivalent and demonstrated working knowledge of cGMP guidelines.
- Interventional vascular products manufacturing experience ideal; class III implant experience preferred. Experience working with high precision, high quality polymer products highly desirable.
- Equivalent combination of education and experience is acceptable.
- Must demonstrate excellent problem solving and project management skills and be a critical analytical thinker with strong attention to detail.
- Must demonstrate effective communication and interpersonal skills and the ability to work in cross functional teams on technology issues and business objectives.