Engineering Manager

Description:

X4 Life Sciences, in partnership with a progressive medical device company in Houston, is seeking a talented and driven Engineering Manager. This role offers the opportunity to lead a multidisciplinary team of approximately 7 engineers across electrical, mechanical, validation, and manufacturing disciplines. The Engineering Manager will drive both strategic initiatives and day-to-day engineering execution in a fast-paced product development environment, focusing on innovative Class II medical devices.

Key Responsibilities:

• Lead and manage a cross-functional team (~7 engineers) in the design, development, validation, and manufacturing transfer of Class II medical devices.

• Provide technical leadership and mentorship across electrical, validation, manufacturing, and R&D engineering disciplines.

• Oversee engineering activities throughout the full product lifecycle: concept, design, verification/validation, and commercialization.

• Ensure compliance with regulatory and quality standards, including FDA, ISO 13485, and 21 CFR Part 820.

• Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure high-quality, timely product delivery.

• Contribute to strategic decisions on design controls, risk management, and continuous improvement initiatives.

• Lead design reviews, V&V planning, root-cause analysis, and problem-solving for development and production issues.

Key Requirements:

• Bachelor’s or Master’s degree in Engineering (Electrical, Mechanical, or related discipline).

• 8+ years of engineering experience in the medical device industry (Class II preferred).

• 2+ years of leadership experience managing multi-disciplinary engineering teams.

• Hands-on technical background spanning Electrical, Validation, Manufacturing, and R&D environments.

• Strong knowledge of regulatory standards: ISO 13485, 21 CFR Part 820, and IEC 60601.

• Excellent communication, leadership, and project management skills.

• Collaborative mindset and ability to thrive in a hands-on technical setting.

Why Apply:
This high-impact leadership role allows you to shape engineering strategy and drive the development of life-changing medical technologies. The company fosters innovation, technical excellence, and continuous growth, providing an opportunity to lead and develop a high-performing engineering team.