1 DNA way South San Francisco, CA 94080
Bayside Solutions is seeking an Engineer II to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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 purposes.
- The level of the position will depend on the qualifications of the selected candidate.
Summary of Qualifications:
- Bachelor’ s degree in Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Mechanical Engineering, or related discipline.
- 2+ years of relevant experience in the pharmaceutical, biotech or medical device industry, or an advanced degree in a relevant discipline; 5+ years of experience required for the Engineer II level.
- Ability to write formative and summative usability study protocols and reports, and author human factors summary reports consistent with health authority expectations. This experience is required for the Engineer II level.
- Ability to work cross-functionally on risk management activities.
- Ability to design instructions for use (IFU) documents and training materials for medical devices/combination products and conducting usability testing of them. This experience is required for the Engineer II level.
- Experience interfacing with external consultancies, or as part of an external consultancy team that supports the design and development of new medical devices is required for the Engineer II level.
- 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 preferred.
- 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.