Staff/Principal Mechanical Engineer

About the role

The Staff/Principal Mechanical Engineer will play a key technical role in the design, development, and advancement of complex Class III implantable medical devices and supporting technologies. The individual will contribute across multiple areas of mechanical engineering including system architecture, structural and reliability engineering, fluid-contacting components, thermal management, subsystem integration, and product development execution.

Responsibilities

• Lead and contribute to the design and development of complex mechanical systems and components for Class III medical devices.
• Support/drive mechanical architecture development, subsystem integration, and product optimization activities across the product lifecycle.
• Translate user needs, system requirements, and clinical inputs into robust engineering solutions.
• Support/drive technical problem solving related to performance, reliability, manufacturability, and product scalability.
• Partner cross-functionally with Electrical, Systems, Software, Manufacturing, Quality, Regulatory, and Clinical teams throughout development activities.
• Support risk management activities including DFMEA, PFMEA, root cause investigations, and mitigation planning.
• Contribute to verification and validation activities including mechanical testing, reliability testing, environmental testing, and failure analysis.
• Support Design History File (DHF) documentation, engineering reviews, and regulatory submissions.
• Apply Design for Manufacturability (DFM), Design for Assembly (DFA), and tolerance analysis principles to product development efforts.
• Support manufacturing process development, design transfer, and production readiness activities as needed.
• Stay current on emerging technologies, materials, manufacturing methods, and engineering tools relevant to implantable medical devices.

Requirements

• BS in Mechanical Engineering or related discipline required; advanced degree preferred.
• 8+ years of experience developing FDA-regulated medical devices or other highly regulated products.
• Experience contributing to the design and development of complex mechanical systems within cross-functional engineering environments.
• Strong understanding of mechanical engineering fundamentals including structural analysis, reliability engineering, materials selection, and tolerance analysis.
• Experience with CAD tools such as SolidWorks, Creo, or NX.
• Familiarity with engineering analysis tools such as FEA and/or CFD is preferred.
• Working knowledge of applicable medical device standards and regulations including ISO 13485, ISO 14971, and design control requirements.
• Experience supporting verification, validation, and engineering test activities.
• Strong communication, collaboration, and technical documentation skills.
• Ability to operate effectively in a fast-paced, evolving, and highly collaborative environment.

Qualifications

• Implantable and/or cardiovascular medical device experience is preferred but not required.
• Willingness to travel up to 10% as needed.