A biotech client is seeking a highly experienced Director of Systems Engineering to lead the systems engineering process from concept to production, ensuring the design, development, integration, verification, and manufacturability of a combination device drug delivery platform meet all technical, regulatory, and safety standards. The Director of Systems Engineering leads the technical core team responsible for the entire engineering process and will work directly with Program Management to decompose the program into manageable and executable sub-projects. A successful candidate will have a proven track record of leading medical device development projects, preferably drug-device delivery systems, and a passion for developing innovative solutions that make a difference in patient care.
This role is onsite in San Diego so needs someone local who can be there 5 days a week!
What You'll Do:
Translate voice of customer and stakeholder needs into system and product requirements, identifies potential hazards, and assesses requirements to ensure that the product meets the user/business needs.
Collaborate with stakeholders to understand business needs, translate them into detailed system requirements, and ensure proper documentation.
Partner with Program Management to structure programs into well-defined sub-projects and ensure successful execution.
Define system architecture, set technical direction, and guide the team on best practices for system design, integration, and testing.
Lead the systems engineering process from requirements development to final integration and test, ensuring all technical aspects are aligned with program objectives. Identify opportunities to optimize system engineering processes, implement new technologies, and enhance system performance.
Oversee Requirements Management, ensuring traceability from system-level requirements to test validation and user needs. Integrate requirements and ensure compliance with FDA, ISO, and other industry standards, for safety, reliability, and certification requirements.
Establish and execute rigorous testing strategies to validate system functionality against requirements and identify potential issues.
Develop and manage test plans, and subsystem integration plans to verify and validate system performance. Ensure seamless integration of subsystems by coordinating with other engineering disciplines.
Skills Needed:
Minimum bachelor's degree in engineering with Mechanical Engineering being preferred
A minimum of 8+ years in the development of complex medical devices or products
Proven track record of successfully leading the technical function in a core team, bringing complex medical device products and systems from concept to market on schedule and within budget.
Hands-on experience with automated test platforms, fluidic system integration with mechanical designs
Experience in model-based systems engineer (MBSE) and digital engineering tools.
Strong understanding of medical device product development process, and experience in the practical implementation of FDA QSR 21 CFR Part 820 and ISO 13485, specifically Design Controls
Solid documentation and data collection practices compliant to FDA QSR 21 CFR Part 820 and ISO 13485 for medical device safety and industry standards
Experience in writing control software (C#/Python) for custom test equipment supporting novel device development
Extensive experience in systems engineering principles and methodologies
Ability to establish and maintain strong relationships with key stakeholders to attain business results.
Management experience of cross functional product development teams
Able to develop, coach, and engage talent, and ensure diverse bench strength
Proven track record of successfully delivering complex system projects
Deep understanding of system architecture, design patterns, and integration techniques
High attention to detail; recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate with people at all levels of the organization and lead with influence
Proactive, forward-thinking, and creative with high ethical standards, leadership skills and ability to influence others to achieve successful outcomes and meet timelines
Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment