Principal I Systems Engineer at Illumina (San Diego, CA)

| San Diego, CA
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The Principal I Systems Engineer will be leading activities that are moving genomics into clinical practice in oncology, pre-natal testing, infectious disease diagnosis, and other emerging markets. In this position, the person will focus on the execution of systems engineering activities and the generation of product development deliverables throughout the development of Illumina's industry-leading DNA Sequencers and the commercialization of new regulated products in all of the worldwide markets that Illumina serves. This person will help foster the growth of the Systems Engineering function and associates by introducing best practices, educating the department on global regulatory requirements, and expanding the capabilities of team. This role requires a broad grasp of multiple areas of engineering physics and chemistry, including molecular assays, optical, thermal, and fluidic systems, electro-mechanical systems, instrument control software/firmware and data analysis pipelines.

  • Drive the execution of system engineering activities and deliverables on RUO/IVD product development projects including definition of system architecture, user needs, requirements, specifications, traceability, risk management (FMEAs, Hazard Analysis, etc.), verification and validation.
  • Ability to work and lead project teams across multiple global sites
  • Provide technical leadership to project teams
  • Create and mature internal design processes, and promote good systems engineering values
  • Drive design decisions and tradeoffs in regulated and non-regulated environments
  • Support the IVD/Dx product development strategy considering all commercial and operational implications. Navigate the different requirements of RUO and IVD products and optimize for the most efficient path to be successful in both markets
  • Lead development teams to ensure completeness of the design history file. Support regulatory submissions (CE-IVD, FDA, and other geographies), including creation, review, and management of technical documents
  • Support change management as a key engineering technical expert for on-market RUO and IVD systems
  • Establish and maintain strong partnership with Marketing, New Product Introduction, QA/Regulatory and Operation teams to ensure seamless transfer of new products into manufacturing and the field
  • Active participant in the growth of a high-performing engineering team that is strong both in technical depth as well as in best practice system engineering

  • 15+ years of product development experience within an R&D or new product development group, the majority of which involved development of complex high-volume products
  • Experience with product development in a regulated and non-regulated environment
  • Demonstrated experience in leading cross functional teams globally
  • Excellent collaboration, relationship building, and influential skills to help team members work toward common goals
  • Strong technical breadth and demonstrated ability to understand and communicate technical information at all levels
  • Experience in applying Design for Six Sigma and System Engineering best practices
  • Experience in Requirement Definition and Architecture
  • Demonstrated experience in characterization and testing of complex instrumentation systems
  • Solid knowledge of regulatory standards such as ISO13485, ISO 14971, 21 CFR Part 11, IEC 60601 and AAMI standards applicable to medical devices
  • Experience in submitting regulated medical device products in China and other OUS markets

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

  • Typically requires a minimum of 15 years of related experience with a Bachelor's degree; or 12 years and a Master's degree; or a PhD with 8 years experience; or equivalent experience

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact [email protected] To learn more, visit:
More Information on Illumina
Illumina operates in the Biotech industry. The company is located in San Diego, CA, Madison, WI, Foster City, CA and San Diego, CA. Illumina was founded in 1998. It has 7400 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 35 open jobs at Illumina, click here.
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