Staff Design Control Engineer

Employer
GRAIL, LLC
Location
Menlo Park, CA
Posted
May 20, 2022
Required Education
Bachelors Degree
Position Type
Full time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

As a key member of the Quality team at GRAIL, the Staff Design Control Quality Engineer plays an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that align with the FDA’s Quality System Regulations (QSRs), ISO 13485, CLIA/CAP, and applicable state requirements. The successful candidate will work with product development teams to ensure that appropriate design control measures are applied during development and transfer of Grail products. The individual will apply “systems” thinking and knowledge of medical device products, molecular diagnostics, applicable industry or regulatory standards, design verification and validation, manufacturing transfer, test method development principles, and risk management to support new and sustaining projects. 
You will:
  • Work effectively and influence multiple functions (R&D, Operations, Product/Program, Regulatory, Supply Chain, Medical, Engineering, etc.) to ensure teams understand and implement appropriate regulations for all areas of design controls, including risk management, development planning, inputs, user needs, design requirements, specifications, traceability, outputs, critical to quality (CtQ), design review, verification, validation, change control, protocols, and reports.
  • Provide QA support for product development from feasibility through transfer into commercialization.
  • Support documentation appropriate for regulatory submissions.
  • Ensure design control documentation and requirements are met. Perform and review/approve design control and risk management activities. Facilitate Design Review activities and assess Quality readiness for Verification and Validation activities.
  • Work closely with research and development organizations to ensure potential product issues are identified and addressed in the design.
  • Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the efficiency of the risk control measures.
  • Develop/lead all aspects of the FMEAs and other risk assessment processes and documentation (as required).
  • Ensure Quality Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971:2012.
  • Anticipate and manage project risks and issues.
  • Work on sophisticated technical problems, apply quality engineering methods and provide innovative solutions.
  • Design, develop, approve, and implement Design Control Quality Systems SOPs, forms, reports, protocols, and documents associated with design controls processes.
  • Provide coaching to QA, product development, key partners on Quality Systems requirements and Design Controls.

Your qualifications and experience will include:
  • Minimum of a Bachelor of Science Degree in a related scientific or engineering field.
  • 8+ years Quality and/or Development experience in product development, product transfer, verification, and validation under Design Controls in the life sciences industry, preferably in a FDA regulated medical device/IVD environment.
  • Solid understanding of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, ISO 14971, CAP/CLIA, and other applicable quality and regulatory standards).Extensive experience and understanding of design, development, verification and validation processes.
  • Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment. Effective verbal and written communication skills and the ability to share and receive information from all levels of the organization throughout various departments.
  • Travel may be required up to 15% of the time, both domestically and internationally.
  • Must be able to work in a biohazard environment and align with safety policies and standards outlined in the Safety Manual.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.