About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the Role

The Sr. Systems Engineer leverages technical feasibility, user needs, risk, and business objectives to deliver high-quality, compliant product solutions across a variety of system components. This role plays a critical part in advancing innovative processes that improve patient outcomes.

What You'll Do

• Translate user needs and clinical requirements into system and subsystem requirements across implantable and external systems.
• Define system architecture, interfaces, and functional partitioning for active implantable platforms
• Maintain end-to-end traceability across user needs, system requirements, design outputs, verification, and validation
• Identify, assess, and manage system-level risks using hazard analysis, DFMEA, and use-related risk methodologies
• Support system integration planning, execution, and characterization activities
• Ensure system testability and contribute to system-level verification and validation strategies
• Evaluate the impact of design changes across the full system and recommend appropriate actions
• Serve as the systems engineering representative on cross-functional product development teams
• Generate and maintain system documentation in compliance with the Quality Management System
• Mentor and guide engineers in systems engineering principles, tools, and best practices.

What We Look For

• Bachelor’s degree in mechanical, biomedical or electrical engineering. 
• Equivalent work experience in a similar role, strongly preferred.
• Minimum of 5 years’ direct experience in medical device industry.
• Experience with requirements management, system architecture, and systems integration
• Knowledge of design controls, risk management, and verification and validation processes
• Strong communication skills with the ability to collaborate across cross-functional teams.
• Master’s degree in engineering or related field
• Experience with active implantable medical devices or complex electromechanical systems
• Familiarity with human factors and usability engineering processes
• Experience supporting regulatory submissions or interactions with the FDA or notified bodies
• Experience working within a regulated quality system environment (e.g., ISO 13485)

Please send resumes to James.Dakin@eci-rx.com or apply online on our careers page: Careers | ECI | Enhanced Compliance Inc. today!

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.