The Senior Engineer will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices 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 interfaces with pre-filled syringes and cartridges.
The Senior Engineer will be assigned responsibilities to perform tasks and will assist other Engineers in developing solutions to problems by addressing issues of moderate scope and complexity.
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. This objective will be accomplished by executing activities in the areas of:
Component selection, assessment of container-device compatibility and container-drug compatibility, development of testing methods to assess container and deliver system quality and functionality for existing and new technologies.
Regularly interface with staff and leaders in Contract Manufacturing, Project Core Teams, Development, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs.
Regularly interacts with external development partners and component suppliers.
Drive problem solving using state of the art tools such as DMAIC, DFFS, DOE, Modelization, Monte Carlo Simulation and Probabilistic Design.
Quality System Compliance:
Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Use local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
Ensure compliance of training to PQS and job-related requirements.
Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Participate in hazards analyses and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
Who You Are
B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
At least 8 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 DOE, problem solving and modelling using physical rules.
Strong skills in relevant modeling, design controls and/or statistical analysis.
Engineering: Mechanical system design, System engineering, Process/Industrial Engineering, Injection molding and Mold-Flow analyses.
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatability, 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
Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.
Excellent communication skills are required. Experience in working with external partners is also highly desirable.
Highly organized and detail oriented.
Excellent leadership skills.
Core training is mandatory and must be completed within the allotted time frame beginning with on-board date. Initial training requirements are listed in this section.
PTD DEV: Device Development Engineer 30 –T 27463760
PTD DEV: Device Development Engineer 90 – T 27463761
Additional training to enhance Core requirements may be assigned. These elective courses are deemed essential to performing the job duties related to this position.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
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.