- This job posting represents two roles we are hiring for.
- This role may be hired as a "Engineer II" or Senior Engineer. The position description is written at the Engineer II level.
Genentech’s Device Development group has an opportunity available for a Human Factors Engineer.
Responsibilities of this position include the following:
- Provides human factors engineering expertise to project teams developing combination product drug delivery devices, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered.
- Collaborates with multi-functional teams including Device Engineering, Regulatory, Clinical, Quality, Marketing, and Program Management to inform and guide development of innovative products and ensure that those products are safe and easy to use.
- As part of product development, conducts human factors engineering activities within device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies.
Develops instructions for use and training materials for clinical trial and commercial
Sjkills / Qualifications:
- Bachelor’s or Master’s degree in human factors engineering, mechanical engineering, bioengineering, or related discipline
- 3+ years of experience in applying HFE to medical device or combination product development
- Experience writing formative and summative usability study protocols and reports and human factors summary reports consistent with health authority expectations
- Experience working cross-functionally on risk management activities
- Experience designing instructions for use (IFU) documents and training materials for medical devices/combination products and conducting usability testing of them
- Experience working with human factors external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices
- Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
- Proven ability to clearly communicate how study results can be implemented into design
- Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combinations products
- Ability to communicate effectively in writing, verbally, and as a presenter
- Demonstrated time management, decision making, presentation, and organization skills
- Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
- High level of initiative and ability
Roche is an equal opportunity employer.Manufacturing, Manufacturing > Production Engineering