Note: The job is a remote job and is open to candidates in USA. Dice is seeking an experienced Systems Design / Product Development Engineer to support the development and lifecycle management of a software-based medical device. This role focuses on design documentation, regulatory compliance, and cross-functional collaboration in a regulated environment.

Responsibilities

• Create, update, and maintain DHF documentation including user needs, design inputs, system requirements, software requirements, traceability matrices, and risk files
• Support design controls and regulatory documentation throughout the product lifecycle
• Participate in risk management activities including FMEA and usability engineering
• Develop, execute, and document Verification & Validation (V&V) protocols, test cases, and reports
• Collaborate with Engineering, Quality, Regulatory, and Clinical teams to ensure compliance with FDA and quality system requirements
• Support documentation remediation and design authority transfer activities

Skills

• 5+ years of Systems Design, Systems Engineering, or Product Development experience in the medical device industry
• Strong hands-on experience creating and maintaining Design History File (DHF) documentation
• Experience with design controls, requirements management, traceability, and risk management
• Knowledge of ISO 14971; familiarity with ISO 62304 and IEC 62366 is preferred
• Experience in FDA-regulated/QMS environments
• Experience drafting requirements, protocols, and executing V&V testing
• Excellent communication and documentation skills
• Experience with Codebeamer, JIRA, or similar requirements management tools is a plus
• Bachelor's degree in Engineering, Biomedical Engineering, or a related scientific discipline
• Experience with Software as a Medical Device (SaMD)
• Previous experience with Zimmer Biomet or Orthogrid projects is highly preferred
• Biomedical Engineering background preferred

Company Overview