Genentech Senior Engineer (Contractor) in South San Francisco, California,
Senior Engineer (Contractor)
South San Francisco, California
Job ID: 202105-111862 (http://jobs.gene.com/202105-111862)
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- The Senior Device Engineer will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices (such as Pre Filled Syringes, Auto Injectors, Patch Pumps etc.) for parenteral pharmaceutical therapeutics at Genentech.
The candidate has technical expertise in the development and commercialization of drug device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within Genentech’s device development programs, including manual injection systems, automated injection systems, and high speed assembly processes. The Senior Device 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 and coordinate work activities of other personnel and may also supervise staff members.
The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines.
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. Please refer to ‘Technical Knowledge’ section for list of potential responsibilities.
Education and Industry Experience:
B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering or equivalent. At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree. Experience in the Medical Device industry is expected
Strong skills in relevant modeling, design controls and/or statistical analysis.
Experience in Structured Product Development using Design Controls in a Medical Device/Combination Product Development industry. Experience in working with technical requirements, Design Verification testing, protocols and reports writing.
Strong Design Skills (i.e. Tolerance Stack up Analysis, Test Method Validation/Gage R&R and Fixture Development, Development of Drawings and Specifications) Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods. Injection molding.
Device Design: CAD (Solidworks/Creo), Rapid prototyping, GD&T, 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.
Excellent communication skills are required. Experience in working with external partners is also highly desirable. Highly organized and detail oriented. Excellent leadership skills.
Ability to visit vendors in the Minneapolis/ St Paul area
This is a temporary assignment. The individual in this role will be employed by a third party, not by Genentech
Roche is an equal opportunity employer.
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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