Sr Manager Design and Construction

What if the work you did every day could impact the lives of people you know? Or all of humanity?

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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.

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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.

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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