Staff Engineer

Staff Engineer, Design Quality - Lifecycle Management
Greater Boston Area

A leading medical device organization is seeking a seasoned Staff Engineer to support a complex, highly regulated product portfolio. This is a true Staff-level role, not a Senior Engineer position, and is ideal for someone with strong technical depth, practical product experience, and the ability to lead lifecycle management activities across Class I, II, and III medical devices.

The ideal candidate will bring a product-first mindset, strong design quality experience, and the ability to make sound, risk-based decisions in a complex engineering and quality environment. This role will support change management, reliability improvements, obsolescence challenges, and ongoing lifecycle management activities across a large medical device portfolio.

Responsibilities

• Manage product and supplier-related change activities, including supplier change requests, component obsolescence, product updates, reliability improvements, and lifecycle management initiatives.
• Make risk-based decision-making related to product safety, compliance, field risk, stop-ship situations, and other business-critical quality or manufacturing concerns.
• Partner cross-functionally with engineering, quality, regulatory, manufacturing, supplier quality, and operations teams to evaluate product impact and determine the appropriate level of action.
• Apply design quality principles to product changes, lifecycle management projects, reliability improvements, and regulated product decision-making.
• Assess technical issues, right-size solutions, and ensure project actions are appropriate to the scope, risk, and compliance impact of the issue.
• Identify gaps across product, quality, and lifecycle management processes and help drive improvements where needed.

Requirements

• Bachelor's degree in electrical engineering preferred, or related technical disciplines may also be considered.
• Minimum of 5+ years of relevant engineering experience in the medical device.
• Hands-on experience with Class I, II, and/or III medical devices.
• Deep understanding of applicable standards (ISO 14971, ISO 10993, IEC 62366, IEC 60601, etc.)
• Hands-on experience with electromechanical medical devices.