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Device Engineer III
Ref No.: 20-02255
Location: South San Francisco, California
Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

Duties:
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:
Device Engineering:
Provide guidance and input regarding product development.
Develop and commercialize devices including interfaces with the primary container.
Provide guidance and input regarding product development
Regularly interface with staff and leaders in Commercial Marketing, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs
Regularly interact with external development partners and components suppliers
Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.
Write and execute protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.
Generate/execute equipment qualification (IQ, OQ, PQ) protocols, provide input, and execute plans to ensure robust equipment operation and data management, and direct others in the execution of protocols.
Design Controls

Skills:
Technical Knowledge:
Application of relevant modeling and design tools, design controls and/or statistical analysis.
Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.
Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc..
Six Sigma (Green/Black Belt): DMAIC and DFSS.
Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses

Education:
· B.S, M.S, Ph.D or advanced degree in Engineering, with preference for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
· At least 5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
· Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on development of injection devices required. Must have prior experience working on primary containers, needle safety systems, injection devices with automated features, and container-device compatibility and interactions.