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Scientific. Clinical. Software Engineering

Associate Scientist

San Mateo Metro Area, CA

Job Type: Scientific Job Number: JN -092020-27360 Region: San Mateo Metro Area

Job Description

Description:

The successful candidate will provide technical contribution on cross functional combination product development teams and/or be a contributor to complex technical development and problem solving. The candidate should be able to conduct design, development and implementation of new drug delivery devices or combination products. The candidate will work with her/his team to ensure that device design, component selection, manufacturability and testing meet the product needs. This person will interface with staff and leaders in Device Development, Quality, Regulatory Affairs, and across biologics product development. He/She should be capable of presenting technical findings at team meetings and management interactions. He/she will be able to conduct technical development with external development partners and component suppliers. In addition he/she will drive problem solving activities using state of the art tool such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design.


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 Education: Engineering degrees or equivalent


Experience:

The right candidate will have 1-5 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.

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