Senior Engineer, Product Lifecycle

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.

Basic Function and Scope of the Position:

The selected candidate will report into the Illumina Life Cycle Management team and support the Operations organization in the areas of manufacturing transfer, design for reliability, manufacturability and trouble-shooting of new product and sustaining and improvement of existing products.

Specifically, the role will be to lead complex cross functional teams through new process & product transfer for in-vitro diagnostics, medical devices.  The engineer needs to be a self-starter, analytically oriented, and able to provide technical leadership in technical and operational support to the process development/ improvements/ sustaining efforts in a high volume, multi-product manufacturing environment.

Tasks and Responsibilities:

• Lead and participates in process sustaining, definition and improvement, design, development and quality test activities in conjunction with Manufacturing, Validation, Supply Chain, Quality Assurance, Facility and Regulatory Affair.
• Ensure system and process equipment are in compliance with quality system and regulatory requirements (MDSAP, ISO 13485, 21CFR820, ISO 13485, ISO 14971).
• Participates in establishing operating process, equipment specifications and improvements.
• Troubleshoots production line issues related to yield, quality and throughput.
• Construct and execute controlled experiments (including DOE's) to optimize processes, address yield and quality issues and drive implementation of solutions into a production environment to meet project goals. Analyzes process test results, issue reports and makes technical recommendations.
• Drives implementation of solutions in a production environment to meet production goals.
• Able to lead CAPA and failure investigation tools and techniques.
• Develop manufacturing work instructions, test methodologies and process flow procedures.
• Works cross functionally with R&D, Manufacturing and Quality to develop processes for new products and improve processes of existing products.
• Defines technical requirements and procedures for manufacturing to process product.

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

Preferred Educational Background:

• Bachelor of Science/ Bachelor of Engineering/ Masters or equivalent in Chemical, Biochemical, Biochemistry and/or Bio-related field.

Preferred Experiential Background:

• 5 - 8 years of relevant experience required.
• Experience in research product development, project management, production support/sustaining and/or process development, design, scale-up, improvement and validation required.
• Work experience in the biotech/pharmaceutical industries and experience in FDA-regulated environment with cGMP knowledge is desirable.
• Ability to collect, prepare, and present relevant information to influence decision-making within the organization.
• Proficiency with chemical processes and analyses.
• Excellent organizational skills and attention to detail required.

Competencies:

• Good documentation skills and ability to write procedures and training manual.
• Basic computer troubleshooting skills.
• Good inter-departmental communication skills. Highly effective communication, facilitation, coaching, and negotiation skills.
• Demonstrated ability to work independently.
• Able to apply DOE techniques, Statistical Process Control knowledge and Statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE)
• Able to analyze data and make logical and rational conclusion

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.