System Engineer II
4300 Hacienda Dr Pleasanton, CA 94588
Bayside Solutions is seeking a System Engineer II to be part of our client’ s team in 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 II
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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 client is building a legacy of innovation to transform next-generation sequencing and its application. The Development Process & Support team is an internal-customer support organization that creates, manages, and improves processes, labs, and infrastructure to support product development teams.
- The Development Process & Support team is in need of a System Engineer II who will participate in the development and adoption of design control processes. In addition, the individual will provide subject matter expertise to internal R&D teams on best practices, methods, and tools pertaining to IVD product development, design control, and documentation.
- Guides engineers and scientists on best practices for design control process and how they can apply them in their projects
- Responds to staff questions and inquiries with clear communication, professionalism, and positivity
- Provides expertise and critical analysis for Design Control deliverables such as risk and requirements management, verification and validation, and design change control
- Manages and supports product development and design control processes, including authoring Standard Operating Procedures and templates and resolving questions about their application
- Develops training content in the form of presentations, process maps, documentation guidance, and website content
- Supports scientific and engineering user group in the usage, training, development and maintenance of engineering and application lifecycle management software tools
- Performs work according to established internal safety guidelines and procedures
- Applies technical principles, tools and knowledge gained from previous work experience to tackle challenges of complexity and diversity of scope
- Works under general supervision (plans and executes own work, is comfortable taking actions and making decisions within the scope of the role)
- Works on a wide range of problems where original contributions are required. Creative, imaginative thinking is required
- Delivers a high quality, thoughtful work product with consideration for multiple stakeholders, including business, regulatory, quality, and product development needs
- Bachelor' s degree in Engineering, Scientific, Quality, Regulatory or related field
- Required BS or equivalent with 2-6 years related experience or MS with 2-3 years related experience or Ph.D. degree; preferred MS with 3+ years related experience
- Formal training in Agile development, Scrum, and/or Kanban methods desirable
- Formal training in System Engineering highly preferred.
- Experience in medical device industry and training in IVD design control processes highly preferred