500 Forbes Blvd South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking an Engineer III 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:
- The engineer is responsible for design, development, and implementation of drug delivery devices for parenteral pharmaceutical therapeutics.
- Primary technologies include vial transfer systems, manual injection systems, automated injection systems, and interfaces with pre-filled syringes.
- The engineer is a technical expert and provides technical leadership in the development and commercialization of new drug-device combination products in collaboration with company’ s engineering, scientific, and manufacturing organizations.
- The engineer will work with his/her team to ensure that device design, component selection, manufacturability and test methods meet product needs.
- Responsibilities include drafting Design Control documents including reports, protocols, plans & specifications, conducting and participating in/leading root cause analyses, participating in cross-functional teams, managing design verification testing and evaluation of device design, assembly & test equipment.
- Drive problem-solving activities using state of the art tool such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design.
- The engineer regularly interfaces with staff and leaders in Device Development and may interface with Commercial Marketing, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical Development, Packaging Development, Quality and Regulatory Affairs.
- The engineer may also interact with external development partners and component suppliers.
Summary of Qualifications:
- Advanced degree (M.S.) in engineering required. Mechanical, Biomedical, Chemical Engineering preferred.
- 4-6 years of relevant experience preferred.
- Experience in full cycle (concept – commercialization) of medical device development, system engineering, injection molding and mold-flow analyses, mechanical modeling methods, medical device risk management, medical device design control requirements, test method development and validation.
- Experience in the Pharmaceutical, Biotech or Medical Device industry is a must, with previous work on development of injection devices required.
- Prior experience working on primary containers, needle safety systems, injection devices with automated features, and container-device compatibility and interactions is highly desired.
- A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable.
- Excellent communication skills are required.