Principal Quality & Software Engineer - Medical - Woburn, MA

We are seeking a Senior Quality Engineer, Medical Devices and Software, to support new product development within our Quality Assurance team in a fast-paced, complex engineering environment. This full-time, on-site role is based in our Burlington, MA office.

Client Details

My client is focused on creating an advanced system to help treat patients with atrial fibrillation (AF), a common heart condition. They are developing innovative technology that provides high-resolution, 3D mapping during heart procedures, enabling precise data collection and improved treatment outcomes. This system is designed to offer real-time insights that will assist doctors in better understanding and addressing AF.

Description

The Principal QE (Medical Device and Software) Will:

• Represent Quality Engineering in design phases: development, verification, validation, transfer, and design reviews (NPD and product realization)
• Participate in risk management throughout product development
• Support design teams (software, data science, hardware/systems) in design controls and SDLC
• Assist sustaining engineering with operational quality: material control, process development, inspections, nonconformance, equipment qualification, and supplier management
• Ensure materials, equipment, and products meet quality specs through inspections and testing
• Design and implement quality processes to meet regulatory standards
• Train cross-functional teams on quality and compliance, mentor QA team members
• Support internal audits and ISO 13485 certification readiness
• Expand knowledge of external standards to ensure compliance for product commercialization

Profile

The Princiapl QE (Medical Device and Software), will have the following experience:

• Bachelor's in Mechanical, Biomedical, or related Engineering field
• 8+ years in Quality Engineering within a regulated industry
• Experience with software, data science, hardware/systems design, and production under a Quality Management System
• Knowledge of 21 CFR 820, ISO 13485:2016, and IEC 62304:2006
• Proven experience in product development lifecycle, SDLC, design controls, and risk analysis
• Strong communication, documentation practices, attention to detail, and project management skills
• 8+ years medical device experience preferred (clients like Medtronic, Boston Scientific, Abbott)
• Experience with systems using input signals for visualization
• NPD experience in Class II or higher medical devices
• Startup experience is a plus
• On-site, full-time, 5 days a week
• C++ and Python experience ideal (C++ for software, Python for data science)

Job Offer

• Annual 10% Bonus
• Stock Options
• Innovative Environment : Work on cutting-edge medical technology and groundbreaking solutions in a fast-growing company.
• Collaborative Team : Join a highly skilled team of professionals dedicated to improving patient outcomes and driving innovation.
• Professional Growth : Opportunities for continuous learning, skill development, and career advancement.
• Competitive Compensation : Receive a strong salary and benefits package, reflecting your skills and contributions.
• Impactful Work : Be part of a mission-driven company focused on revolutionizing healthcare technology.
• Comprehensive Benefits : Enjoy health, dental, vision coverage, and more.

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.