Medical Device Manufacturing Process Engineer
2 weeks ago
EXECUTIVE SUMMARY
The Senior Process Engineer will be responsible for providing drug delivery device production innovation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.
The candidate has in depth experience in high volume manufacturing processes and methodologies and leads process development to support clinical and commercial production activities within Genentech’s device development programs. This includes engaging internal partners and external design/development/manufacturing partners and component suppliers.
The Senior Process Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance to and coordinate work activities of other personnel. The work is reviewed with a focus on long-term perspectives, as the candidate establishes his/her own work priorities and timelines.
QUALIFICATIONS
Education and Industry Experience
B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.
At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
In depth experience in high volume manufacturing processes and methodologies, with an emphasis in plastic molding and mechanical assembly is expected.
Demonstrated success in project planning, resource management, liaison with engineering and manufacturing resources in other countries is critical.
Experience working with control systems to be used in production and batch release.
Strong expertise with statistical handling and interpretation of data, technical report writing and reviewing.
Familiarity with risk management tools; develop FMEAs of the products and ability to assess changes, non-compliances, etc., with risk assessment methods.
TECHNICAL KNOWLEDGE
Strong skills in relevant modeling and design tools, design controls and/or statistical analysis. Examples may include:
At least 5 years experience supporting process development from feasibility to New Product Introduction
Interaction with Equipment/Process: Plastic Heat stake, Plastic Laser welding, Laser Etching, Zebra Printers,
Leak tests (pressure decay), Flow test, Bubble test, drop test, Pull test, semi-automated and automated
Assembly equipment, Functional Testers, Smart-scopes, Height gauges, Vision Systems
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Device Design: CADD (Solidworks, AutoCad), Design for Manufacturability, Molding.
Full data and statistical analysis (JMP, Minitab) and Design of Experiments, and providing detailed review of data with an emphasis on statistics.
Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, User Requirement Specifications (URS), Factory/Site Acceptance Testing (FAT/SAT), test protocols, technical reports, control systems to be used in production and batch release and risk management tools (methods, FMEAs, non-compliances, etc)..
Six Sigma (Green/Black Belt): DMAIC and DFSS
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