Title: Senior Development Engineer
Location: Gaithersburg MD/ South San Francisco CA
Duration: 12 months
The successful candidate will be able to lead device development initiatives which may include combination product development, technology assessment or development, and/or be a senior contributor to complex technical development and problem-solving.
The candidate should be able to conduct the design, development, and implementation of new drug delivery devices or combination products.
The candidate will be accountable for the overall technical success of the project. He/She will work with her/his team to ensure that device design, component selection, manufacturability, and testing meet the product needs.
This person will regularly interface with staff and leaders in Device Development and other relevant functions like device quality.
He/she will be able to lead technical development with external development partners and component suppliers. In addition, he/she will drive problem-solving activities using state-of-the-art tools such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design.
Major Duties and Responsibilities:
• Strong technical contributor to a cross-functional team in the assessment, evaluation, selection, and development of drug delivery devices for the AstraZeneca pipeline
• Be a senior engineering 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
• 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.)
• Ability to develop and implement best practices/business processes
• Education: Engineering degrees or equivalent
The right candidate will have 8+ years of experience in device development and/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 to ensure the success of projects. 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.
As a Kelly employee, you’ll have access to premier perks, including:
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