QvalFocus Inc. is seeking an experienced Hardware Engineer to support new product development for Class III medical devices. The role involves hardware design, development, verification & validation, risk management, and design transfer while ensuring compliance with regulatory requirements.
Responsibilities:
- Design and develop mechanical and electrical hardware components for new medical device products
- Create and maintain hardware specifications, drawings, and bills of materials (BOMs)
- Support hardware verification & validation (V&V) activities and testing protocols
- Perform hardware risk analysis, including FMEA and risk mitigation activities
- Collaborate with software, systems, manufacturing, quality, and product development teams throughout the product lifecycle
- Support design transfer, manufacturability, and component sourcing activities
- Ensure compliance with ISO 13485, FDA regulations, and Design Control processes
Requirements:
- Experience in hardware engineering within regulated medical device or life sciences environments
- Knowledge of FDA 21 CFR 820, ISO 13485, Design Controls, and risk management processes
- Strong troubleshooting, analytical, and communication skills