Senior Design Control Engineer

Insight Global; Houston (TX); On-site; USD 83,000 - 110,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Design Controls

Design Reviews

Documentation

Regulatory Audits

Risk Management

Cross-functional collaboration

Regulatory Knowledge

Education

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

Job description

We are seeking a Senior Design Control Engineer to support the development and commercialization of complex medical devices. This individual will work closely with cross-functional engineering, quality, regulatory, project teams, and external stakeholders to plan and execute design control activities throughout the product development lifecycle. The Senior Design Control Engineer will be responsible for leading and supporting design control strategies, Design Reviews, Design History Files (DHFs), and product risk management activities to ensure development documentation is complete and supports timely product registrations and successful audits. The role will assess proposed design changes, determine appropriate change and regression-testing strategies, and help ensure continued product safety and performance. This individual will also support the investigation and resolution of defects, non-conformances, CAPAs, and change-control activities, while coordinating documentation-control activities with internal teams and third-party suppliers. The engineer will help prepare and defend design-control documentation during internal and external audits, support remediation activities when necessary, and contribute to the continuous improvement of design-control practices. Candidates must be willing to go onsite in Houston, Tx. Pay range: $60-80/hr based on experience.

Skills and Requirements

PhD in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Software Engineering, or a closely related engineering discipline required. 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 Design History Files (DHFs) in support of regulatory submissions and internal or external audits. Strong working knowledge of 21 CFR 820.30 and ISO 13485 within medical device product development. Experience with ISO 14971 risk management, including risk analysis and identification of appropriate risk-control measures. Experience evaluating design changes and determining appropriate verification, validation, and regression-testing activities to demonstrate product safety and performance. Experience supporting change control, non-conformances, CAPA, and defect investigation/resolution within a regulated medical-device environment. Ability to work cross-functionally with Engineering/R&D, Quality, Regulatory, project teams, and external suppliers throughout product development. Strong technical writing skills with the ability to develop and defend documentation during internal and external audits. Experience with applicable medical-device standards such as IEC 62304, IEC 60601-1, and/or ISO 10993 preferred. Experience with complex electro-mechanical-software medical devices preferred; active implantable or neuromodulation device experience is a plus.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].