Lead Systems Architect

ZEISS • Dublin, CA

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About The Position

Lead Systems Architect oversee the concept, development, and maintenance of the Chronic Disease Management (CDM) R&D Program Portfolio. This role provides technical and methodological guidance to product systems engineers, builds program-wide technical expertise, and establishes a robust technology and applications network both internally and externally. This position reports directly to the Head of R&D Workflow Glaucoma & Comprehensive Care and plays a critical role in defining system architecture, driving innovation, and ensuring the technical functionality of the product portfolio throughout its lifecycle. You will also work closely with the Advanced Development of the Strategic Business Unit Ophthalmology (OPT) and the Digital Business Unit of Carl Zeiss Meditec (DBU) to align long-term research initiatives with product development and strategic innovation goals. You will collaborate with cross-functional teams, external stakeholders, and key opinion leaders (KOLs) to deliver impactful solutions to the market.

Requirements

• Bachelor's degree in Business Administration, Engineering or Scientific field is preferred.
• Minimum of seven (7) years relevant work experience in quality assurance for medical devices with at least 3 years in a leadership role.
• Experience working with quality systems, including the design and implementation thereof, required.
• Extensive experience in enterprise IT Systems from a Quality System perspective.
• Experience in ERP systems, such as SAP,CRM, Agile and Sharepoint is desired.
• Extensive knowledge of ISO 900 I :2000, ISO13485:2003, and 21 CFR Part 820 quality systems is required.
• Broad knowledge of global regulations is preferred.
• Excellent Project Management skills.
• Understanding of statistical techniques such as normality analysis, confidence intervals and should be able to analyze and interpret data with high confidence, preferred.

Nice To Haves

• Knowledge or prior work experience in one or more of the following areas: Medical electronic instruments, ophthalmic instruments, imaging or non-imaging optics.
• Image processing, machine vision systems, human vision.
• Modeling and simulation tools (MATLAB, Matrixx, Mathematica).
• PC applications and OEM integration.
• Displays, medical safety/regulatory agency compliance testing and requirements.
• Experience in influencing global standards and best practices.
• Proven ability to manage medium to large-sized projects without supervision.

Responsibilities

• Systems Engineering Leadership Direct systems engineering activities across the CDM product portfolio and guide systems engineering teams to: Provide leadership in system architecture and modular design breakdown.
• Define, analyze, and document specifications for tradeoffs, performance, features, controls, and operations.
• Identify areas of technical risks and develop mitigation plans.
• Lead system integration across specialist areas of a product.
• Plan and conduct in-depth reviews, testing, and verification/validation of product features.
• Critically analyze and verify system performance through simulation, testing, and measurements.
• Technical Contributions Provide major contributions to designs, including algorithm development and validation of critical technology components.
• Specify and develop improvements or enhancements to existing products and champion their implementation when necessary.
• Create system definitions, concepts, and technical product specifications optimized for customer value, cost, and timing.
• Lifecycle Management & Standards Ensure overall system functionality of the product portfolio throughout its lifecycle.
• Develop design and documentation standards for the CDM Systems Engineering Team.
• Collaborate with other ZEISS entities to establish and maintain global standards and best practices.
• Ensure systems engineering practices align with product development processes.
• Cross-Functional Collaboration Work extensively with Marketing, Product Management, and other engineering teams (Mechanical, Electrical, Software) to translate business needs into technology solutions.
• Support product systems engineers in developing and negotiating external product specifications with product management and customers.
• Act as the operational technical customer interface at the portfolio level and represent ZEISS at public meetings and conferences.
• Technology Roadmap & Communication Set requirements for the technology roadmap and drive technology decisions within CDM.
• Communicate technology status, roadmap, and future opportunities to senior management and business leaders.

Benefits

• This position is eligible for a Performance Bonus.
• ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level