Summary

Illumina is a global leader in genomics technology, founded in 1998 and headquartered in San Diego, California. As a pioneering biotechnology company, Illumina specializes in developing, manufacturing, and marketing integrated systems for genetic analysis, with a primary focus on DNA sequencing and array-based technologies. The company's mission is to improve human health by unlocking the power of the genome, serving customers across research, clinical, and applied markets worldwide. Illumina's innovative platforms, including the NovaSeq, HiSeq, MiSeq, and NextSeq series, have revolutionized genomic research and clinical applications, enabling breakthroughs in personalized medicine, disease research, and drug development. With over 9,000 employees across 27 countries, Illumina has established itself as the dominant force in next-generation sequencing, processing more than 90% of all DNA sequencing data globally. The company's technologies support diverse applications from cancer research and rare disease diagnosis to agricultural genomics and infectious disease surveillance, making genomic insights accessible to researchers and clinicians worldwide.

Job description

Responsibilities

Drive staff results by communicating job expectations, planning, monitoring and appraising job results, coaching and counseling employees, recognizing performance issues and driving improvement, developing, coordinating and enforcing systems, policies, procedures and productivity standards
Establish strategic goals by gathering pertinent business, financial, service and operations information, choosing a course of action, defining objectives, and evaluating outcomes
Maintain staff by recruiting, selecting, orienting and training employees; maintaining a safe, secure and legal work environment; developing personal growth opportunities
Ensure validation program meets requirements of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP
Identify differences between ISO and FDA requirements and their applicability to products targeting different markets
Report broadly through the organization on validation activities and instrument manufacturing audit readiness
Estimate timelines and budgeting for validation engineering development efforts
Formalize, standardize and document processes
Assist development and manufacturing engineering in designing, performing, and improving verification tests
Participate as an active member on new product development teams
Interact with cross-disciplinary project teams in order to meet project milestones and end goals
Work with scientists, technicians, engineers, marketing, and project management to deliver commercial and internal genetic analysis systems
May lead cross-functional teams to address system issues

Requirements

5-7 years managing a mid-size (6-10 FTE) team with demonstrated ability to coach, mentor, develop and discipline
Experience in the medical device/IVD industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods
Experience in both front room and back room audit support
5-7 years experience in manufacturing, quality assurance or engineering in an FDA regulated environment
Knowledge and working application of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP requirements
Knowledge and working application of Validation Principles, guidelines and industry practice
Proven ability to lead in a continuous improvement environment, identify the end state and lay out a step-by-step plan for attainment while messaging broadly achievable timelines
Knowledge and working application of FMEA and Risk Analysis
Demonstrated strong analytical problem solving (CAPA)
Solid understanding of manufacturing processes in medical device manufacturing
Strong verbal and written communication skills are required
Experience supporting the transition of an RUO manufacturing line to Dx/IVD control a strong plus
Experience with statistics, Statistical Process Control and DOE techniques is a plus
The ability to discuss technical topics with non-technical people is strongly desired
Six Sigma Black Belt certification, PMP certification, ASQ accreditations a plus

Requirements

5-7 years managing a mid-size (6-10 FTE) team with demonstrated ability to coach, mentor, develop and discipline
Experience in the medical device/IVD industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods
Experience in both front room and back room audit support
5-7 years experience in manufacturing, quality assurance or engineering in an FDA regulated environment
Knowledge and working application of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP requirements
Knowledge and working application of Validation Principles, guidelines and industry practice
Proven ability to lead in a continuous improvement environment, identify the end state and lay out a step-by-step plan for attainment while messaging broadly achievable timelines
Knowledge and working application of FMEA and Risk Analysis
Demonstrated strong analytical problem solving (CAPA)
Solid understanding of manufacturing processes in medical device manufacturing
Strong verbal and written communication skills are required
Experience supporting the transition of an RUO manufacturing line to Dx/IVD control a strong plus
Experience with statistics, Statistical Process Control and DOE techniques is a plus
The ability to discuss technical topics with non-technical people is strongly desired
Six Sigma Black Belt certification, PMP certification, ASQ accreditations a plus

Benefits

Health insurance
Dental insurance
Vision insurance
Retirement benefits
Paid time off
Family planning
Genomics sequencing access

Company overview

Illumina is a global leader in genomics technology, founded in 1998 and headquartered in San Diego, California. As a pioneering biotechnology company, Illumina specializes in developing, manufacturing, and marketing integrated systems for genetic analysis, with a primary focus on DNA sequencing and array-based technologies. The company's mission is to improve human health by unlocking the power of the genome, serving customers across research, clinical, and applied markets worldwide. Illumina's innovative platforms, including the NovaSeq, HiSeq, MiSeq, and NextSeq series, have revolutionized genomic research and clinical applications, enabling breakthroughs in personalized medicine, disease research, and drug development. With over 9,000 employees across 27 countries, Illumina has established itself as the dominant force in next-generation sequencing, processing more than 90% of all DNA sequencing data globally. The company's technologies support diverse applications from cancer research and rare disease diagnosis to agricultural genomics and infectious disease surveillance, making genomic insights accessible to researchers and clinicians worldwide.