Medical Device - Sr. Systems Engineer - Southborough, MA

• Contribute to next-generation systems in a dynamic environment.
• Join a team of 5 reporting into the Sr. Director of R&D.

About Our Client

My client leads the charge in cardiac medical innovation, developing a groundbreaking system that has already transformed treatment for patients worldwide. Their cutting-edge technology seamlessly integrates advanced platforms offering new hope for those battling medical disorders.

Job Description

Main Duties and Responsibilities Include:

• 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.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The Successful Applicant:

• 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.

What's on Offer

What's To Offer:

• 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.

Contact

Josephine Belcher

Quote job ref

JN-122024-6611384