Staff Engineer, Design Quality & Lifecycle Management

About

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 right 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 product changes, supplier-related changes, reliability improvements, obsolescence challenges, and ongoing lifecycle management activities across a large medical device portfolio.

Key Responsibilities

• Manage product and supplier-related change activities, including supplier change requests, component obsolescence, product updates, reliability improvements, and lifecycle management initiatives.
• Support 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.
• Provide mentorship and technical guidance to less experienced engineers.
• Identify gaps across product, quality, and lifecycle management processes and help drive improvements where needed.
• Support quality system updates where they connect directly to product, design quality, lifecycle management, and risk mitigation.
• Communicate effectively with engineering and cross-functional stakeholders, including the ability to challenge assumptions and influence decisions in a practical, professional manner.

Ideal Background

• Bachelor's degree in Electrical Engineering preferred; Mechanical Engineering, Systems Engineering, Biomedical Engineering, or related technical disciplines may also be considered.
• Approximately 5–7+ years of relevant engineering experience in the medical device or similarly regulated industry.
• Experience in product development, design engineering, design quality, lifecycle management, reliability engineering, or product-focused quality engineering.
• Prior experience supporting Class I, II, and/or III medical devices.
• Strong understanding of how design, quality, regulatory, manufacturing, supplier changes, and product risk connect across the product lifecycle.
• Practical experience managing or supporting supplier changes, product changes, component obsolescence, reliability improvements, or lifecycle management projects.
• Ability to provide specific examples of projects personally owned or directly supported.
• Experience making risk-based decisions where safety, compliance, technical complexity, and business needs must all be balanced.

Technical & Regulatory Knowledge

Working knowledge of applicable medical device standards and regulations, including some or all of the following:

• ISO 14971 — Risk Management for Medical Devices
• ISO 13485 — Medical Device Quality Management Systems
• ISO 10993 — Biological Evaluation / Biocompatibility
• IEC 62366 — Usability Engineering / Human Factors
• IEC 60601 — Electrical Safety and Essential Performance
• IEC 62304 — Medical Device Software Lifecycle Processes

Candidates do not need to be subject matter experts in every standard, but should understand how these standards apply to product changes, lifecycle management, design quality, risk assessment, and regulated decision-making.

Experience with products containing software is strongly preferred. This person does not need to be a software engineer, but…