Principal Engineer, Product Development (Medical Devices)

Location: Methuen, Massachusetts, United States; onsite

Company

Develops medical devices and surgical technologies designed to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Define systems engineering strategy, architecture, technical standards, and technology roadmaps for assigned product lines.
• Lead system architecture, integration, requirements, interface definitions, and technical specifications across multidisciplinary teams.
• Drive system-level analyses, trade studies, risk assessments, and safety risk management throughout product development.
• Ensure compliance with design controls, verification and validation requirements, quality standards, FDA requirements, and international regulations.
• Translate clinical and customer needs into product strategies while assessing emerging technologies, technical feasibility, and portfolio opportunities.
• Provide technical leadership and mentorship, influence engineering direction, and improve systems engineering processes and practices.

Requirements

• Master’s or PhD in Electrical Engineering, Physics, Computer Science, Systems Engineering, or a related technical discipline.
• 15+ years of progressive engineering experience with significant systems engineering, product development, and technical leadership responsibility.
• Successful leadership of complex product development programs from concept through commercialization in a regulated environment.
• Deep knowledge of system architecture, requirements management, system integration, verification, validation, and risk management.
• Strong understanding of medical device design controls and applicable FDA and international regulatory requirements.
• Ability to influence technical direction, lead cross-functional teams without direct authority, mentor engineers, and shape engineering strategy.

Nice to have

• Experience with complex electromechanical, software-driven, robotic, navigation, imaging, or surgical systems.
• Experience with FDA submissions, global product registrations, and regulatory interactions.
• Working knowledge of ISO 14971 and related medical device standards.

Culture & Benefits

• Values innovation, customer focus, teamwork, and decisive execution.
• Collaborative work with engineering, clinical, quality, regulatory, manufacturing, and commercial functions.
• Inclusive and respectful equal opportunity workplace.