Staff Product Development Engineer

Overview

The Staff Product Development Engineer will lead the end-to-end development of complex, interventional medical devices within a contract development environment, serving as a technical lead for programs executed on behalf of external clients across a broad range of medical devices technologies. This role owns activities from concept generation and detailed CAD design through prototyping, verification, and risk management. It requires deep technical expertise, strong customer-facing communication, and the ability to independently solve complex, system-level problems while driving design for manufacturing, quality compliance, and clinical study support. The engineer will provide technical leadership across multiple projects, mentor junior engineers, and actively contribute to process improvement and organizational growth.

Responsibilities

• Leads end-to-end medical device development programs, owning scope, timelines, technical execution, risk management, and delivery across multiple concurrent projects.
• Serves as technical and project lead for customer engagements, driving meetings, proposals, schedules, and decision-making while identifying unmet client needs and new technology opportunities.
• Designs, builds, and evaluates device concepts through hands-on prototyping and rigorous testing, including development of fixtures, test methods, study protocols, and technical reports.
• Owns design controls activities, including requirements development, risk analysis, verification strategies, and compliance with Quality System and product development process requirements.
• Demonstrates advanced SolidWorks proficiency to execute and review complex models and assemblies, while coaching junior engineers on best practices in CAD and design intent.
• Breaks down complex system-level challenges into actionable plans, independently driving progress with minimal oversight and escalating strategically when needed.

Required Qualifications

• 7+ years' experience in the medical device design/development field.
• Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or an equivalent.
• Strong understanding of ISO 13485, sufficient to participate in an audit and/or guide junior engineers.
• Demonstrates ownership, clear communication, and a strong sense of urgency.
• Advanced SolidWorks skills.
• Experience in catheter-based or minimally invasive device development strongly preferred.
• Proficient in Microsoft Office: MS Project, Excel, PowerPoint, Teams, Outlook.

Physical Demands

• Ability to stand and walk for short periods of time during prototyping, testing, and collaboration activities.