Senior Design & Construction Manager, Medical Devices

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

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.