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?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.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 standardsEstablish strategic goals by gathering pertinent business, financial, service and operations information, choosing a course of action, defining objectives, and evaluating outcomesMaintain staff by recruiting, selecting, orienting and training employees; maintaining a safe, secure and legal work environment; developing personal growth opportunitiesEnsure validation program meets requirements of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAPIdentify differences between ISO and FDA requirements and their applicability to products targeting different marketsReport broadly through the organization on validation activities and instrument manufacturing audit readinessEstimate timelines and budgeting for validation engineering development effortsFormalize, standardize and document processesAssist development and manufacturing engineering in designing, performing, and improving verification testsParticipate as an active member on new product development teamsInteract with cross-disciplinary project teams in order to meet project milestones and end goalsWork with scientists, technicians, engineers, marketing, and project management to deliver commercial and internal genetic analysis systemsMay lead cross-functional teams to address system issuesRequirements:12 years of related experience, with 3-6 years of Management experience. Experience in the medical device/IVD industry in the development and deployment of Quality Systems, process controls, and continuous improvement methodsExperience in both front room and back room audit support5-7 years experience in manufacturing, quality assurance or engineering in an FDA regulated environmentKnowledge and working application of FDA (21 CFR Part 11 and Part 820), ISO 9001/13485, IEC 62304 and MDSAP requirementsKnowledge and working application of Validation Principles, guidelines and industry practiceProven 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 timelinesKnowledge and working application of FMEA and Risk AnalysisDemonstrated strong analytical problem solving (CAPA)Solid understanding of manufacturing processes in medical device manufacturingStrong verbal and written communication skills are requiredExperience supporting the transition of an RUO manufacturing line to Dx/IVD control a strong plusExperience with statistics, Statistical Process Control and DOE techniques is a plusThe ability to discuss technical topics with non-technical people is strongly desiredSix Sigma Black Belt certification, PMP certification, ASQ accreditations a plusListed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.The estimated base salary range for the Sr Manager Design and Construction role based in the United States of America is: $155,600 - $233,400. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. 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 View email address on click.appcast.io. To learn more, visit: 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.SummaryLocation: US - California - San DiegoType: Full time