System Engineer I
4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a System Engineer I to be part of our client’ s team in the Tri Valley. 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
System Engineer I
- 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 position of System Engineer plays a key role at client site in the development and validation of instrument systems for running molecular diagnostic tests for the In Vitro Diagnostics (IVD) global market place.
- Participate in technical projects per the client Life Cycle Management and product development processes.
- Develop automated processes for running molecular-based diagnostic assays on instrumentation that perform liquid handling, sample processing, and optical signal analysis.
- Carry out tasks as necessary to run test campaigns to verify requirements and design specifications, and ensure conformance to intended use of products.
- Collect, analyze, and develop report packages to support system verification and validations, and compile content for regulatory submissions.
- Conduct reliability analysis, testability analysis, software reliability, fault tolerance, and system stress analysis on instrument systems that run diagnostic assays.
- Participate on project team through the steps of design, development, and validation.
Summary of Qualifications:
- B.S. or M.S. in Engineering, Physical, and/or Biological Sciences, or related field.
- Experience in automating assay processes on instrumentation that perform liquid handling, sample processing, and optical signal analysis.
- Experience in product development, systems engineering, and verifying system performance by testing is required.
- Expertise in the areas of microfluidics, optical subsystems, robotic handling, and integration of biochemical reagents onto instruments is required.
- Experience in medical device software development and validation is strongly desired.
- Knowledge and experience with PCR assays and associated data analysis methods is a plus.
- Training or experience in the use of industry standard reliability tools, process capability analysis, and use of computers and IT systems is also desired.
- Candidates with additional knowledge and experience in the processes associated with IVD product development would be prioritized. Such processes include requirements management, risk analysis, verification and validation, and usability engineering.
- Exceptional people skills, strong communication, flexible personality, able to work independently and as part of a team.
- Strong skills in writing technical reports and verbally communicating technical content in oral presentations
- Excellent problem solving skills and ability to work with minimal direction