Device Engineer III
1 DNA way South San Francisco, CA 94080
Bayside Solutions is seeking a Device 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.
Device Engineer III
- 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.
- The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.
- Provide guidance and input regarding product development.
- Develop and commercialize devices including interfaces with the primary container.
- Provide guidance and input regarding product development
- Regularly interface with staff and leaders in Commercial Marketing, Clinical Sciences, Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs
- 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.
- Write and execute protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.
- Generate/execute equipment qualification (IQ, OQ, PQ) protocols, provide input, and execute plans to ensure robust equipment operation and data management, and direct others in the execution of protocols.
- Design Controls
Summary of Qualifications:
- B.S, M.S, Ph.D or advanced degree in Engineering, with preference for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
- At least 5 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 development of injection devices required. Must have prior experience working on primary containers, needle safety systems, injection devices with automated features, and container-device compatibility and interactions.
- Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering
- Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
- Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, 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