Sr. Systems Engineer

Role: Sr. Systems Engineer

Onsite Position - Local Candidates
Location: Santa Clara, CA

Summary:
We are looking for a passionate Senior Systems Engineer to join our Systems Development Group to
support the Next Generation Sequencing (NGS) products. The candidate is expected to be a hands-on
contributor in feasibility, development and integration, verification, and validation phases of end-to-end
NGS solutions, while following applicable regulatory, quality, and safety standards.
Responsibilities:
The responsibilities for this position include, but are not limited to, the following:
Develop and deploy and test a wide range of technologies, including sample extraction, library
prep, and sequencing.
Organize and drive systems development activities as part of the project team to develop new
NGS solutions, and ensure the product design meets customer needs as well as applicable
regulations or standards. May serve as the Systems representative on cross-functional teams
and efforts, as needed.
Participate in developing and managing requirements on various levels and traceability analysis.
Develop, execute and document test cases for verification and validation. Ensures complete and
comprehensive coverage of requirements in the test campaigns.
Plan and prioritize activities / assignments to support team members.
Perform system integration and testing activities and verify system performance through
simulation, test, and measurements. Assess results for applicability, validity, and conformance
to product requirements.
Participate in story / backlog review, debugging, and defect management of software platforms
that are part of the end-to-end solution.
Work independently with general management direction to drive product development and
collaboration to identify opportunities for continuous improvement.
Perform product risk management activities using tools such as Hazard Analysis or Failure
Modes and Effects Analysis (FMEA) according to Roche s applicable regulatory and quality
standards and provides risk mitigation recommendations to the project team.
Collaborate with project teams and internal/external stakeholders to create project artifacts and
maintain related documents in Design history files.
Keep supervisor/project leader informed of project status, particularly of significant findings and
results in critical problem areas.
Perform work according to established internal safety guidelines and procedures, and as
specified by appropriate external regulatory agencies.
Maintain compliance as required by regulatory bodies and the company s quality system;
Who you are
You re someone who wants to influence your own development. You re looking for a company where
you have the opportunity to pursue your interests across functions and geographies.
Where a job title is not considered the final definition of who you are, but the starting point.
Qualifications:
Bachelor s degree in Chemistry, Biology, Biomedical Engineering, System engineering or related
disciplines. Advanced degree preferred.
Required BS or equivalent with 5+ years related experience; or MS with 4+ years related
experience; preferred MS with 6+ years related experience
3+ years hands-on experience with DNA sequencing such as raw sample preparation, nucleic
acid extraction, library preparation and common NGS sequencers or Digital PCR platforms.
Proven hands-on troubleshooting experience and skills in wet bench workflows.
Strong analytical, problem solving, communication, and interpersonal skills and fast learner.
Preferred Qualifications:
Experience with statistical tools (e.g. Python/JMP for regression analysis, ANOVA) and Design of
Experiments methodology
Knowledge in other aspects of NGS workflow such as nucleic acid chemistry, primer design
technologies for gene targets is highly desirable
Experience with automation solutions is highly desirable
Industry experience of product development to launch is highly desirable
Knowledge of imaging processing and imaging data handing is desirable
Knowledge of software development practices, testing, and software as a medical device is preferred

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