San Mateo Metro Area, CA
Major Duties and Responsibilities:
Strong technical contributor to a cross functional team in the selection, development, scale up and commercialization of drug delivery devices for the company pipeline
Be a scientific contributor to complex problem solving and technical development
Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertise
Influence and educate cross-functional stakeholders on device development and commercialization best practices
Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations
Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. risk management, Design Controls, ISO standards etc.)
Contribute to regulatory filings
Ability to develop and implement best practices / business processes
Engineering degrees or equivalent
The right candidate will have 5+ years experience in medical device or combination product development. Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products and the level of position being interviewed for.
Other Skills and Qualifications:
In addition, the candidate should have excellent leadership skills and ensure success of the project. Experience in working with external companies is also highly desirable. A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is a must. Excellent communication skills are required.