This position is for a hybrid Quality Assurance / Product Engineer role at our Oakland, CA office. Our company needs a product engineer who can manage NextGen Jane’s product pipelines, including supplier evaluation, manufacturing, troubleshooting, and testing. This role also includes developing and maintaining our Quality Management System including developing procedures, systems, and auditing per medical device regulations (21CFR820 & ISO13485), including design and document controls.
Primary Duties and Responsibilities
- Lead multi-collaborative relationships in every stage of manufacturing from vendors to consultants and contractors involved in the product lifecycle
- Lead cross-functional teams to find and manage contract manufacturers for NGJ’s medical devices and laboratory tests. This will include troubleshooting efforts of NGJ’s products and manufacturing processes
- Maintain Quality Management System, including writing and updating product documentation as necessary as well as developing systems to appropriately handle documentation, product and vendor relationships
- Lead design verification and validation testing efforts including developing appropriate testing protocols based on written specifications and design input requirements
- Coordinate builds of NGJ’s devices, ensuring sufficient quantity and quality of product is manufactured
- Manage product inventory, both at NGJ and at external vendor sites
A master’s degree or equivalent work experience is required (undergraduate degree and 1-2 years of work experience is sufficient). Experience in a regulated product environment (i.e., medical devices, contract manufacturing for medical devices, pharma). Interest in developing systems in an innovative company environment. Preferred candidates will be adaptable, with strong cross-functional communication skills and an interest in reproductive health.