Senior Design Control Engineer - Medical Devices

Insight Global; Houston (TX); Sur place; USD 83 000 - 110 000; Plein temps

Résumé du poste

Insight Global is seeking a Senior Design Control Engineer to lead and support design-control activities for complex medical devices through development and commercialization stages. You will coordinate DHFs, design reviews, and risk management while engaging engineering, quality, regulatory teams, and external suppliers to ensure compliance and readiness for audits.

The role requires a PhD in a related engineering discipline, hands-on regulatory experience, and strong technical writing

Qualifications

• PhD in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Software Engineering, or a closely related engineering discipline.
• Hands-on experience supporting medical device product development and Design Controls, including planning design-control activities, conducting Design Reviews, and maintaining compliant development documentation.
• Experience developing, maintaining, reviewing, or remediating DHFs for regulatory submissions and audits.
• Strong working knowledge of 21 CFR 820.30 and ISO 13485 in medical device product development.
• Experience with ISO 14971 risk management, including risk analysis and risk-control measures.
• Experience evaluating design changes and determining verification, validation, and regression-testing activities.
• Experience supporting change control, non-conformances, CAPA, and defect investigation in regulated medical-device environment.
• Ability to work cross-functionally with Engineering/R&D, Quality, Regulatory, project teams, and external suppliers.
• Strong technical writing skills to defend documentation during audits.
• Experience with IEC 62304, IEC 60601-1, and ISO 10993 preferred.
• Experience with complex electro-mechanical-software medical devices is a plus.

Responsabilités

• Plan and execute design-control activities throughout the product development lifecycle.
• Lead and support design-control strategies, DHFs, and design reviews.
• Coordinate documentation-control with internal teams and third-party suppliers.
• Assess proposed design changes and determine appropriate regression-testing strategies.
• Prepare and defend design-control documentation during audits and inspections.
• Support CAPAs, non-conformances, and change-control activities.
• Contribute to continuous improvement of design-control practices.

Connaissances

Design Controls

Design Reviews

Documentation

Regulatory Audits

Risk Management

Cross-functional collaboration

Regulatory Knowledge

Formation

PhD in Biomedical / Electrical / Mechanical / Systems / Software Engineering or related

Description du poste

Insight Global is seeking a Senior Design Control Engineer to lead and support design-control activities for complex medical devices through development and commercialization stages. You will coordinate DHFs, design reviews, and risk management while engaging engineering, quality, regulatory teams, and external suppliers to ensure compliance and readiness for audits.

The role requires a PhD in a related engineering discipline, hands-on regulatory experience, and strong technical writing