Michael Page
Medical Device - Sr. Systems Engineer - Southborough, MA
Michael Page, Southborough, Massachusetts, United States, 01772
As a Systems Engineer you will design and develop innovative hardware and software solutions for complex medical devices, contributing to significant improvements in patient care. You will collaborate with cross-functional teams to turn innovative ideas and user needs into life-saving technologies. This position will be essential in defining and delivering the next generation of pulsed-electric field systems.
Client Details
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.
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. Profile 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. Job 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. 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.
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.
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. Profile 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. Job 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. 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.