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.

Illumina is seeking an experienced Senior Systems Engineer to join the R&D Engineering team. This role will focus on execution of Product Development deliverables, design controls and general Systems Engineering activities. Role will also assist in creating documentation for regulatory submission (CE-IVD, FDA).

Responsibilities:

• Participate as an active member on PD teams to execute and drive product development process and systems engineering principles with a focus on instrumentation and hardware related areas in regulated and non-regulated products.
• Work with subject matter experts to drive execution of project risk management activities in compliance with the risk management process and industry best practices (FMEAs, Hazard Analysis, etc.).
• Contribute to the development of appropriate product design user needs, requirements, specifications, and traceability throughout the product design history file.
• Execute specific deliverables associated with development of RUO and/or IVD products, including but not limited to design verification, specification management, and traceability.
• Support activities of regulatory submission, including creation, review, and management of technical documents.
• Learn and understand the applicable technology and engage in technical discussions.
• Execute good systems engineering values and industry standard best practice.

Requirements:

• Minimum of 5 years experience within a product development environment working as a Systems Engineer or related role.
• Must have experience with product development in medical diagnostics, IVD regulated space.
• Must have experience with risk management activities and analysis techniques (FMEA, FTA, Hazard Analysis).
• Solid knowledge of regulatory standards such as ISO 13485, ISO 14971, 21 CFR Part 11, and AAMI standards as applicable to medical devices.
• Demonstrate cross-functional ability to accomplish goals while working across departments.
• Experience in creating, reviewing, and updating technical documentation under regulated and non-regulated environment.
• Demonstrated ability to understand and communicate technical information.
• Strong interpersonal and organizational skills.

Education:

• Bachelor of Science degree or higher, in Engineering, or related field.

#LI-ONSITE

The estimated base salary range for the Senior Systems Engineer role based in the United States of America is: $88,200 - $132,400. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

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 accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. This role is not eligible for visa sponsorship.