Senior Product Engineer

Illumina is seeking a Senior Product Engineer for the Consumables Manufacturing Technology and Transfer (MTT) group. This role is integral to Consumables Manufacturing, focusing on new product introduction and enhancing quality and yield in high-volume production. The individual will represent MTT on teams developing RUO and IVD library preparation, sequencing, and micro-array based assay reagents and consumables. Responsibilities also include supporting new corporate and business development partnership opportunities and ensuring operational deliverables are met.

Must Have

• Accountable for operation’s deliverables for new product introduction and operations partnership projects.
• Establish manufacturing and QC process requirements to meet product specifications.
• Ensure projects meet required design history deliverables for clinical or RUO products.
• Collaborate closely across all of Global Operations to present a unified voice to product development teams.
• Provide operational support and content for proposed business development deals (with manager’s oversight).
• Assist with the resolution of non-conformances and complaints generated within the early launch period.
• Present clear and concise written and oral communications to colleagues and supervisors.
• Author technical operations documents, such as plans/protocols, engineering reports, SOPs.
• Release documents, bills of materials and device master record data into ERP system.
• Demonstrated ability to problem solve, provide supporting evidence, propose solutions, make decisions, and build consensus.
• Ability to communicate effectively and build strong relationships across multiple departments.
• Ability to work in fast-paced environment; easily adaptable to changing priorities.
• Knowledgeable of ISO 13485, ISO 14971, 21 CFR 820 / 11.
• Experience with statistics, Statistical Process Control and DOE techniques.
• B.S./M.S. in Chemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics, Biological Sciences, Materials Science or Physical Chemistry or equivalent discipline.
• 5+ years of industry experience with an MS/BS, or 0+ years of experience with Ph.D.

Good to Have

• Knowledge of Molecular Biology basics and DNA sequencing.
• Work experience with product development, project management, design change control programs.
• Experience with high-tech consumables manufacturing, validated manufacturing systems, and process validation procedures.

Perks & Benefits

• Access to genomics sequencing
• Family planning
• Health/dental/vision benefits
• Retirement benefits
• Paid time off

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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.

Position Summary:

We are looking for a technical expert for our Consumables Manufacturing Technology and Transfer (MTT) group. The MTT group works as an integral part of our Consumables Manufacturing process and is tasked with new product introduction and increasing quality and yield within our high-volume production environments.

This individual will be accountable for representing MTT on a single or multiple teams focused on development and transfer to Operations of RUO and IVD library preparation, sequencing, and micro-array based assay reagents and consumables. In addition, this person will perform Operations assessment and support of new corporate and business development partnership opportunities such as co-development, co-marketing, divestitures, acquisitions, supply-outs, OEM/Distribution, and Clinical Diagnostics Pharma partnerships.

Responsibilities:

• Accountable for the operation’s deliverables for new product introduction and operations partnership projects.
• Establish manufacturing and QC process requirements to meet product specifications.
• Ensure the projects meet the required design history deliverables as needed for clinical or RUO products.
• Collaborate closely across all of Global Operations to present a unified voice to the product development teams.
• With manager’s oversight, provide operational support and content for proposed business development deals.
• Assists with the resolution of non-conformances and complaints generated within the early launch period, and ensures lessons learned are incorporated into future product development programs.
• Present clear and concise written and oral communications to colleagues and supervisors, lead and participate in technical meetings, and provide recommendations based on results.
• Author technical operations documents, such as plans/protocols, engineering reports, SOPs.
• Release documents, bills of materials and device master record data into ERP system.

Requirements:

• Demonstrated ability to problem solve, provide supporting evidence, propose solutions, make decisions, and build consensus in a multi-disciplinary, cross-departmental environment.
• Ability to communicate effectively and build strong relationships across multiple departments.
• Ability to work in fast-paced environment; easily adaptable to changing priorities.
• Knowledgeable of ISO 13485, ISO 14971, 21 CFR 820 / 11
• Experience with statistics, Statistical Process Control and DOE techniques.
• Knowledge of Molecular Biology basics and DNA sequencing preferred.
• Experience troubleshooting a variety of object-oriented programming languages (R, Camstar MES, VENUS)
• Work experience with product development, project management, design change control programs is preferred.
• Experience with high-tech consumables manufacturing, validated manufacturing systems, and process validation procedures is a plus.

Education / Experience:

• B.S./M.S. in Chemical Engineering, Bioengineering, Biotechnical Engineering, Bioinformatics, Biological Sciences, Materials Science or Physical Chemistry or equivalent discipline.
• 5+ years of industry experience with an MS/BS, or 0+ years of experience with Ph.D.

The estimated base salary range for the Senior Product Engineer role based in the United States of America is: $98,400 - $147,600. 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.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative 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 offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. 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. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.