Job Title:
System Engineer

Location:
Remote

Job Description:

Key Responsibilities:
- Develop and implement robust design control processes in compliance with FDA regulations (21 CFR 820) and ISO 13485.
- Ensure traceability between user needs, design inputs, verification, and validation activities.
- Collaborate with cross-functional teams to ensure that design validation meets user expectations and regulatory requirements.
- Support and contribute to design verification and validation (V&V;) activities to confirm product functionality and compliance.
- Maintain and update Design History Files (DHF) and other critical documentation required for regulatory compliance.
- Prepare and manage design control documentation to support internal and external compliance audits.




- Identify and recommend process improvement opportunities to enhance efficiency in design control and traceability methodologies.

Required Qualifications:
- 5-8 years of experience in system engineering within a regulated environment, preferably in the medical device industry.
- Strong expertise in design controls, traceability, and risk management processes.
- Comprehensive knowledge of FDA regulations (21 CFR 820), ISO 13485, and related quality and regulatory standards.

Preferred Qualifications:
- Experience with risk management processes (ISO 14971) and implementing risk mitigation strategies.
- Familiarity with verification and validation (V&V;) practices and methodologies.
- Proficiency in using requirements management and traceability tools.

📌 System Engineer (México)
🏢 Intellectt
📍 México