We are seeking an experienced Systems Engineer with a strong background in medical device product development, Design Controls, traceability, and Design Verification & Validation (V&V;).

The ideal candidate will have experience working within regulated environments and will play a key role in ensuring user needs are effectively translated into design inputs, verification activities, and design validation throughout the product development lifecycle.

This role requires strong cross-functional collaboration with Engineering, Quality, Regulatory, and Product Development teams to ensure compliance with FDA regulations, ISO standards, and internal quality requirements.

Key Responsibilities

- Lead and support Design Controls activities for new and existing medical device products in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory standards.
- Establish and maintain end-to-end traceability between user needs, design inputs, risk controls, verification activities, and design validation requirements.
- Collaborate with cross-functional teams to ensure user needs are appropriately translated into product requirements and validated through documented evidence.
- Support the development, review, and maintenance of Design History Files, trace matrices, and validation documentation.
- Partner with hardware, software, systems, quality, and regulatory teams to ensure proper integration of design controls throughout the product lifecycle.
- Support and coordinate Design Verification and Validation activities to ensure products meet functional, performance, and regulatory requirements.
- Prepare, review,



and maintain technical documentation, engineering records, protocols, reports, and design-control deliverables.
- Provide project updates related to scope, timelines, risks, and compliance status to leadership and stakeholders.
- Identify opportunities for process improvements related to design controls, traceability, and systems-engineering practices.
- Support remediation, compliance, and quality-improvement initiatives as needed.

Required Qualifications
- 10+ years of Systems Engineering experience within the medical device industry or another highly regulated environment.
- Strong experience with Design Controls, traceability management, and Design Verification & Validation.
- Experience establishing traceability from user needs through design validation and product release.
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, and medical device regulatory requirements.
- Experience working within cross-functional engineering and quality teams.
- Excellent written and verbal communication skills in English.
- Strong analytical, organizational, and problem-solving abilities.
- Detail-oriented, with the ability to manage multiple priorities in a rapid-paced environment.

Preferred Qualifications
- Experience with risk-management processes and ISO 14971.
- Familiarity with risk analysis, risk assessment, and mitigation activities.
- Experience with requirements-management and traceability tools.
- Knowledge of V&V; methodologies, protocols, and regulatory-documentation practices.
- Prior experience supporting remediation or compliance-driven projects.

📌 System Engineer (Hyderabad)
🏢 Tekone It Services
📍 Hyderabad