Staff/Senior Staff Product Lifecycle Management (PLM), Continuous Improvement Analyst

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/Senior Staff PLM, Continuous Improvement Analyst, is a subject matter expert responsible for the business capability roadmap covering Illumina's global product lifecycle management processes and technologies. This is a team lead role requiring experience in PLM requirements and a proven ability to collaborate with functional leads, global process owners, and subject matter experts across all sites. Success will be measured by the system and process optimization that directly improves Illumina's ability to innovate both with new product delivery and on-market product updates while assuring compliance to ISO13485, MDSAP, IVDR, and other regulatory requirements. Stakeholders include Quality, Manufacturing Operations, Manufacturing Technology & Transfer, Supply Chain, Product Development, On-market Platform Management, Commercial, Finance, and Regulatory Affairs.

Responsibilities:

• Collaborate with various functional leaders, including Global Information Services (GIS) to define and maintain a multi-year business capability roadmap for PLM.
• Oversee successful delivery of new capabilities, organize user acceptance testing, gather feedback across the organization and work with cross-functional resources to ensure organizational readiness.
• Work with PLM, GIS, cross functional, and cross site leadership to ensure organizational change management (OCM) practices are integrated into the delivery plan and effective at identifying and prioritizing opportunities to improve solution adoption.
• Partner with the Training & Communications team to ensure work instructions, web-based training, quick reference guides, and other job aids are available and effective at supporting the global userbase
• Lead workshops, and business process design sessions in support of continuous improvement and optimization
• Establish key performance indicators (KPIs) to measure and monitor process health
• Demonstrate the ability to balance long-term strategic thinking with tactical shorter-term execution.
• Develop and coach employees across functions and sites.
• Lead by example and display Illumina Leadership Values.
• Embrace and thrive in a fast paced, complex, often ambiguous environment where innovation is at the heart of all that Illumina does
• Work in accordance with documented policies and procedures for achieving and maintaining the required level of product quality in preparation for our customers, the FDA, and ISO third-party audits.
• Participate in corrective action programs (e.g., audits, inspection, recalls, field corrections) to ensure timely follow-up, completion, and documentation of corrective actions
• Work with other teams and within other business processes to ensure support of our overall Quality Management System.
• Other such duties that may be determined by Management.

Listed responsibilities are an essential, but not an exhaustive list of duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• Good understanding and ability to apply experience in meeting requirements of FDA regulatory environment (CFR Part 820), 501k Premarket Notification, and ISO 13485
• Experience with document and material change and configuration activities within a Product Lifecycle Management (PLM) system, Siemens Teamcenter preferred
• Effective failure investigation, technical report writing, data mining, trend analysis, and statistical analysis
• Experience in quality management system /regulatory and/or compliance audits is beneficial
• Managers at this level may become involved in elevated issues arising from daily activities
• Ability to influence individuals and functions to improve our product and process quality
• Effective oral, written, and presentation skills; ability to articulate clear and concise messaging, and leverage data to support desired outcomes
• Ability to adapt quickly to change, possess a high degree of initiative and ownership, and excel in a fast-paced environment
• Ability to collaborate across sites and establish consistency across a global organization

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:

Staff PLM, Continuous Improvement Analyst

• Typically has 7+ years of direct work experience, with a minimum of 1-3 years as a team lead.
• Requires Bachelor's degree, preferably in a technical field, advanced degree (Master's) beneficial.
• Experience in configuration management, master data management, and/or quality management within a regulated environment required.

Senior Staff PLM, Continuous Improvement Analyst

• Typically has 10-12+ years of direct work experience, with a minimum of 3-6 years as a team lead.
• Requires Bachelor's degree, preferably in a technical field, advanced degree (Master's) beneficial.
• Experience in configuration management, master data management, and/or quality management within a regulated environment required.

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 [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf