What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
Summary:
The Staff 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 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.
Responsibilities:
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Drive execution of the system engineering activities on IVD product development projects, including development of product design user needs, requirements, specifications, traceability, verification and validation
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Support the IVD/Dx product development strategy considering all commercial and operational implications. Navigate the different requirements of RUO and Dx products and optimize for the most efficient path to be successful in both markets.
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Participate as an active member on product 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.
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Ability to work and lead project teams across multiple global sites.
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Manage execution of specific system level engineering deliverables associated with development of RUO/IVD products.
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Work with cross-functional teams to translate user needs to system-level requirements.
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Support change management as a key engineering technical expert for on-market RUO and Dx systems.
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Drive decisions and tradeoffs in regulated and non-regulated environments.
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Maintain strong partnership with New Product Introduction, QA/Regulatory and Operation teams to ensure seamless transfer of new products into manufacturing and the field.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Requirements:
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Typically requires a minimum of 8 years of related experience with a Bachelor’s or Master's degree; or 5 years with a PhD; or equivalent experience. Degree preferably in Engineering, Materials Science, or related field.
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Experience with product development in a regulated and non-regulated environment.
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Demonstrated experience in leading cross functional teams globally.
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Excellent collaboration, relationship building, and influential skills to help team members work toward common goals.
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Strong technical breadth and demonstrated ability to understand and communicate technical information at all levels.
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Experience in applying Design for Six Sigma and System Engineering best practices.
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Experience in Requirement Definition and Architecture
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Experience with a variety of risk analysis techniques, i.e. FMEA, FTA within a product development environment working at the system level.
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Experience creating and updating design documentation (DHF)
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Experience with developing and executing design verification/validation protocols.
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Demonstrated experience in characterization and testing of complex instrumentation systems.
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Solid knowledge of regulatory standards such as ISO13485, ISO 14971, 21 CFR Part 11, IEC 60601 and AAMI standards applicable to medical devices
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Experience in submitting regulated medical device products in China and other OUS markets
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Desirable: Specific experience in development of next generation sequencing and/or molecular diagnostic products
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Desirable: Experience with supporting on market products Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Experience/Education:
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Typically requires a minimum of 8 years of related experience with a Bachelor’s or Master's degree; or 5 years with a PhD; or equivalent experience
Illumina believes that everyone has the ability to make an impact, and 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.
