SYSTEMS ENGINEERING AND ANALYSIS

Description:
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 8+ years related experience; or MS with 4+ years related experience; preferred MS with 6+ years related experience; or PhD with 2 year related experience ;end-to-end NGS application development experience is encouraged to apply but could be subject to a level re-calibration.
• 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. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.