System Engineer

Job Title: System Engineer
Location: Remote
Duration: 12-24 Months
Job Summary:
We are looking for a System Engineer with 5–8 years of experience in the medical device industry. The ideal candidate should have strong experience in Design Controls, Traceability, and Design Verification & Validation (V&V) within a regulated environment.
Key Responsibilities:
Support and manage Design Control activities in compliance with FDA and ISO 13485 standards.
Maintain traceability from user needs through design inputs, verification, and validation.
Collaborate with cross-functional teams including Software, Hardware, Quality, and Regulatory.
Support Design Verification & Validation (V&V) activities and documentation.
Prepare and maintain Design History Files (DHF) and related project documentation.
Identify process improvements and support product development activities.
Required Qualifications:
5–8 years of System Engineering experience in medical devices or regulated industries.
Strong knowledge of Design Controls, Traceability, and V&V processes.
Familiarity with FDA 21 CFR 820, ISO 13485, and risk management concepts.
Experience with requirements management and traceability tools.
Strong analytical, communication, and problem-solving skills.
Preferred:
Experience with ISO 14971 risk management.
Exposure to V&V tools and methodologies.
Ability to work independently and in cross-functional teams.