Device Engineer III

2 weeks ago

South San Francisco, United States The Fountain Group Full time

Pay: $49.12-63.74


Length – 1 year contract (available for extension/conversion as well)


Job Description:

The Device Engineer II 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 Device Engineer II will be assigned responsibilities to perform tasks and will assist Senior Device Engineers in identifying and defining critical project steps, and develop practical and thorough solutions to problems.

The candidate will work with general direction and may also supervise staff members.

The work is reviewed upon completion.

Job Responsibilities

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. This includes creation of technical requirements, test methods/fixtures, Verifying requirements through Design Verification and use of engineering analysis tools
  • Create drawings (2D, 3D), perform tolerance stackup analysis, use statistics and Design of Experiments to evaluate design performance, perform Root Cause Analysis
  • Develop and commercialize devices including interfaces with the primary container.
  • 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.



Qualifications:

  • Degree and 5+ years
  • Experience in the Pharmaceutical, Biotech or Medical Device industry is preferred, with previous work on development of injection devices.
  • Design Control, design verification, design validation, failure modes effects and analysis, risk management plans, change management.

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