QvalFocus Inc.Remote
Hardware Engineer – New Product Development
United States of America
Full Time
2 weeks ago
H1B Sponsor Likely
Key skills
Hardware designHardware developmentHardware verification and validationRisk managementDesign transferISO 13485FDA 21 CFR 820Design ControlsFMEAMechanical hardware componentsElectrical hardware componentsRisk ManagementCommunication
About this role
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