Med Device Systems Engineer

Med Device Systems Engineer

Seeking a full-time Systems Engineer to join our team in Marlborough, MA. In this role, you will design and develop cutting-edge hardware and software solutions for complex medical devices, making a real impact on patient care. You’ll collaborate with cross-functional teams to transform innovative ideas and user needs into life-saving technologies. This position will play a critical role in the definition and delivery of our next generation pulsed-electric field systems.

Key Responsibilities

• Act as the primary technical interface between engineering teams, product managers, and external stakeholders, clearly communicating system requirements, updates, and technical challenges.
• Develop and define the overall system architecture and design, ensuring compliance with regulatory requirements and industry standards.
• Collaborate with cross-functional teams, including R&D, clinical, and regulatory, to gather and analyze requirements to ensure alignment with user needs and product goals.
• Conduct and document risk assessments throughout the design and development phases, identifying potential hazards and implementing mitigation strategies per ISO 14971 standards.
• Develop test plans, procedures, and protocols for system integration and verification testing, ensuring that all system components function cohesively and meet design specifications.
• Oversee system validation activities to confirm that devices meet user needs and intended use cases in simulated or actual use environments.
• Ensure all design and development activities adhere to regulatory requirements (e.g., FDA, CE, MDR), and maintain detailed, accurate documentation throughout the product lifecycle.
• Create models and simulations to predict system behavior, assess feasibility, and refine designs before prototyping.

Qualifications

• Bachelor’s degree in an Engineering related field (Master’s preferred).
• 5 years of experience in the medical device industry required.
• Experience with hardware and software development lifecycles, including requirements gathering, design, development, testing, and integration.
• Intimate knowledge of medical device regulations (e.g., FDA, ISO 13485, IEC 62304) and design control processes.
• 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.

Skills

• Excellent communication and project management skills, capable of driving cross-functional and global teams.
• Strong analytical and problem-solving abilities in complex systems.
• Familiarity with project management methodologies and technical project estimation.
• Ability to effectively manage scope changes and perform impact assessments.