709 Sandoval Way Woburn, MA 94544 US
The Hayward, California plant is a new production site for production of a Class III devices. The Manufacturing Manager will be the most senior position at the Hayward site collaborating with the device developer. The position has overall responsibility for production at the site.
- Oversee all functions of Manufacturing Operations
- Maximize capacity and ensure highest quality at the lowest cost in a safe working environment.
- Produce product from sales forecast while adhering to manufacturing budget
- Supervise Manufacturing personnel and be the site leader for all of operations.
- Manage scale up of USA Manufacturing of the liquid embolics product lines.
- Ensure all product are manufactured to specifications and within medical device regulations
- Ensure product, process, equipment and cleanroom are appropriately calibrated and validated to medical device manufacturing standards.
- Coordinate and manage specific projects including site start up.
- Bachelors' degree in Science, Engineering or related discipline
- 10 years experience in a medical device with experience leading manufacturing operations.
- Management of diverse and multidisciplinary teams
- Experience leading, building and developing high impact multidisciplinary teams
- Excellent written and verbal skills and ability to influence others across the organization
- Strong interpersonal and collaboration skills demonstrated in a medical device setting
- Execution focused, able to move from hands on tasks to providing guidance to the team and in turn enable it to achieve success
- Strong track record in effectively building and managing a high performing teams to achieve stretch goals, while not afraid to hold others accountable and give them timely and direct feedback
- Thorough knowledge of the current medical device quality and regulatory requirements required.
- Work with Quality to ensure quality standards are maintained
- Collaborate with Corporate EHS to ensure health and safety regulations are met.
- Work with Engineering to ensure successful integration of new products and processes
- Domestic travel - 10-20%
Pay Rate Range: $50-65/hr. Salary will be commensurate with experience
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