Sr Manager Design and Construction

Illumina; San Diego (CA); On-site; USD 156,000 - 233,000; Full time

Job summary

Illumina in San Diego, CA, seeks a Sr Manager Design and Construction to lead validation and manufacturing readiness for medical devices, ensuring compliance with FDA 21 CFR Part 11/820, ISO 9001/13485, IEC 62304 and MDSAP.

You will coach a 6–10 person team, drive continuous improvement, manage budgets and timelines, and collaborate with R&D, QA, and manufacturing to deliver Dx/IVD products.

Qualifications

• 5-7+ years managing a mid-size team (6-10 FTE) in a medical device setting.
• Experience in development and deployment of Quality Systems, process controls, and continuous improvement methods.
• Knowledge of FDA (21 CFR Part 11/820), ISO 9001/13485, IEC 62304 and MDSAP.
• Experience leading audits (front room and back room) and cross-functional teams.
• FMEA, Risk Analysis and CAPA processes and statistics (DOE, SPC) are required or strongly preferred.
• Six Sigma Black Belt, PMP, or ASQ accreditations are a plus.

Responsibilities

• Drive staff results by setting expectations, planning, coaching, and evaluating performance.
• Establish strategic goals by gathering business and operational information and defining objectives.
• Maintain staff through recruiting, training and creating a safe and compliant environment.
• Ensure validation programs meet FDA/ISO/IEC/MDSAP requirements and user needs.
• Lead cross-functional product development and manufacturing teams to timelines.
• Interact with scientists, engineers, marketing, and project management to deliver Dx/IVD systems.
• Manage budgets, timelines and documentation for validation activities.

Skills

Staff management

Coaching & mentoring

Analytical problem solving

Cross-functional leadership

Verbal & written communication

Continuous improvement

FMEA & Risk Analysis

CAPA

DOE techniques

Project budgeting & scheduling

Education

Regulatory/compliance expertise in medical devices

Tools

FDA 21 CFR Part 11/820

ISO 9001/13485

IEC 62304

MDSAP

Six Sigma Black Belt

PMP

ASQ accreditation

Job description

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 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

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 [e-mail].

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.

The potential of genomics to change the world is unparalleled. At Illumina, we are leading the way. Our technology empowers researchers and clinicians globally to improve cancer treatments, change the course of diseases, protect the environment, and fight food insecurity. We are made up of dedicated professionals, all‑in on creating a better world – and we need every skill set on our path to making genomics useful for all.

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