[reputed company Device Systems Engineer (W2 Only)
Note: The job is a remote job and is open to candidates in USA. reputed company is seeking an reputed company 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
- reputed company, 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 reputed company scientific discipline
- Experience with Software as a Medical Device (SaMD)
- Previous experience with reputed company or Orthogrid projects is highly preferred
- Biomedical Engineering background preferred
Company Overview