Director of Systems Engineering

Our client, a prominent biotech company based in the United States, is currently seeking a highly experienced Director of Systems Engineering to join their team. At our company, we are dedicated to developing cutting-edge medical technologies that improve patient care. We pride ourselves on our commitment to innovation, safety, and regulatory compliance. As a Director of Systems Engineering, you will lead the entire engineering process for our combination device drug delivery platform from concept to production. You will work closely with cross-functional teams to ensure that all technical, regulatory, and safety standards are met throughout the development lifecycle.

The ideal candidate for this role will have a minimum of 8+ years of experience in developing complex medical devices or products. You should have a proven track record of successfully leading technical teams and bringing medical device products to market on time and within budget. Additionally, you must possess strong communication skills and be able to collaborate effectively with stakeholders to translate business needs into detailed system requirements. A background in Mechanical Engineering is preferred, along with hands-on experience in automated test platforms and fluidic system integration.

As the Director of Systems Engineering, your responsibilities will include translating customer needs into product requirements, defining system architecture, overseeing requirements management, and establishing rigorous testing strategies. You will also be responsible for ensuring compliance with FDA regulations and industry standards throughout the development process. The successful candidate will have a deep understanding of system architecture, design patterns, integration techniques, and systems engineering principles.

This role offers a competitive salary of $220K plus bonus potential. If you are passionate about driving innovation in the medical device industry and have a strong track record of delivering complex system projects successfully, we encourage you to apply. This position is ideal for experienced professionals looking to take on leadership roles in technical product development within the biotech sector. Join us in making a difference in patient care through innovative solutions!

• 8+ years in the development of complex medical devices or products
• Extensive experience in systems engineering principles and methodologies
• Management experience of cross functional product development teams
• Minimum bachelor’s degree in engineering with Mechanical Engineering being preferred
• Hands-on experience with automated test platforms, fluidic system integration with mechanical designs
• Experience in model-based systems engineer (MBSE) and digital engineering tools

• Translate voice of customer and stakeholder needs into system and product requirements
• Collaborate with stakeholders to understand business needs, translate them into detailed system requirements, and ensure proper documentation
• 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

• Mechanical Engineering
• Systems Engineering Principles
• Automated Test Platforms
• Fluidic System Integration
• Model-Based Systems Engineer (MBSE) Tools

Seniority Level: Executive Level

• Middle Management
• Senior Level

Job Functions: Engineering

• Program Management
• Product Development

Industries : Biotechnology

• Medical Devices
• Drug Delivery Systems