Job Title: System Engineer

Location: 100% Remote

Industry: Medical Device

Job Overview

We are seeking an experienced Systems Engineer with extensive medical device industry experience and a strong background in Systems Engineering, Design Controls, requirements management, traceability, and Design Verification & Validation (V&V;).

The adecuado candidate will have a proven track record of working in highly regulated environments and supporting the complete product development lifecycle—from translating user needs into design inputs and system requirements through verification, validation, and product release.

This role will work closely with Engineering, Quality, Regulatory, Software, Hardware, and Product Development teams to ensure compliance with applicable FDA regulations, ISO standards, and internal quality requirements.

Key Responsibilities

- Lead and support Design Control activities for new and existing medical device products in accordance with FDA requirements, ISO 13485, and applicable regulatory standards.
- Develop and maintain end-to-end requirements traceability linking user needs, system requirements, design inputs, risk controls, verification activities, and design validation.
- Translate user needs and product requirements into clear, measurable, and testable system-level requirements.
- Partner with cross-functional engineering teams to ensure requirements are properly defined, documented, reviewed, and verified.
- Support and coordinate Design Verification and Design Validation (V&V;) activities, including protocols, test requirements, results, and reports.
- Develop, review,



and maintain Design History File (DHF) documentation, requirements specifications, traceability matrices, and other design-control deliverables.
- Collaborate with Hardware, Software, Systems, Quality, Regulatory, and Product Development teams to ensure effective integration of systems engineering and design controls.
- Ensure product requirements and design outputs appropriately address identified product risks and risk controls.
- Prepare and review engineering documentation, technical reports, verification protocols, validation documentation, and other regulatory records.
- Provide technical and project updates regarding scope, timelines, risks, deliverables, and compliance status to project leadership and key stakeholders.
- Identify and implement opportunities to improve systems engineering, requirements management, traceability, and design-control processes.
- Support remediation, compliance, CAPA, quality improvement, and other regulatory-driven initiatives as required.
- Participate in design reviews and provide systems-engineering expertise throughout the product lifecycle.

Required Qualifications

- 15+ years of Systems Engineering experience, preferably within the medical device industry or another highly regulated environment.




- Strong hands-on experience with FDA Design Controls, requirements management, traceability, and Design Verification & Validation (V&V;).
- Demonstrated experience establishing and maintaining traceability from user needs through design inputs, requirements, risk controls, verification, validation, and product release.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and applicable medical device regulatory requirements.
- Experience working with cross-functional Engineering, Quality, Regulatory, Hardware, Software, and Product Development teams.
- Experience supporting the development and maintenance of DHF, requirements specifications, traceability matrices, V&V; documentation, and engineering records.
- Strong analytical, organizational, documentation, and problem-solving skills.
- Excellent written and verbal communication skills in English.
- Ability to manage multiple priorities and work effectively in a fast-paced, highly regulated environment.

Preferred Qualifications

- Experience with ISO 14971 and medical device risk management.
- Hands-on experience with risk analysis, risk assessment, risk controls, and mitigation activities.
- Experience using requirements management and traceability tools.
- Strong understanding of V&V; methodologies, test protocols, acceptance criteria, and regulatory documentation.
- Experience supporting remediation, compliance, or design-history-file remediation projects.
- Experience working on complex medical device products involving hardware and software systems.

📌 System Engineer (México)
🏢 Intellectt
📍 México