Medical Device - Sr. Systems Engineer - Southborough, MA

PageGroup • Southborough, MA

406d • $120,000 - $150,000

About The Position

As a Senior Systems Engineer, you will be responsible for designing and developing innovative hardware and software solutions for complex medical devices, significantly improving patient care. This role involves collaborating with cross-functional teams to transform innovative ideas and user needs into life-saving technologies, particularly focusing on the next generation of pulsed-electric field systems.

Requirements

• 5+ years of experience in the medical device industry required.
• Bachelor's degree in an Engineering related field (Master's preferred).
• Strong understanding of system architecture and integration principles, including requirement traceability and interface management.
• Experience collaborating with global teams to execute on time and on budget.
• Intimate knowledge of medical device regulations (e.g., FDA, ISO 13485, IEC 62304) and design control processes.
• Experience with hardware and software development lifecycles, including requirements gathering, design, development, testing, and integration.
• Ability to effectively manage scope changes and perform impact assessments.
• Strong organizational skills with attention to detail, especially for regulatory compliance documentation.
• Strong analytical and problem-solving abilities in complex systems.
• Excellent communication and project management skills, capable of driving cross-functional and global teams.
• Familiarity with project management methodologies and technical project estimation.

Responsibilities

• Serve as the primary technical liaison across engineering, product management, and external stakeholders, translating complex system requirements and technical challenges.
• Design comprehensive system architecture with rigorous regulatory compliance and industry standard adherence.
• Lead cross-functional collaboration to synchronize requirements across R&D, clinical, and regulatory teams.
• Conduct systematic risk assessments following ISO 14971, identifying and mitigating potential device hazards.
• Develop comprehensive test protocols for system integration and verification, ensuring cohesive component functionality.
• Execute system validation to confirm device performance in simulated and real-world environments.
• Maintain meticulous regulatory documentation for FDA, CE, and MDR compliance throughout product lifecycle.
• Generate predictive models and simulations to optimize design feasibility and performance before prototyping.

Benefits

• Competitive salary ranging from $120K to $150K, reflecting your skills and experience.
• Comprehensive health benefits, including dental, vision, and life insurance, ensuring your well-being.
• 401(k) plan with company matching to help you build a secure financial future.
• Employee stock options, giving you the opportunity to share in the company's success and growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree