Job Title: Director of Engineering

Work Location: Houston, Texas

Summary:

Seeking a Director of Engineering to oversee engineering and R&D projects, ensuring deliverables, timelines, and budgets are met while maintaining design controls and compliance with regulatory standards. This leadership role requires coordination across multiple teams and disciplines to achieve organizational goals in the medical device sector.

Responsibilities:

• Lead and coordinate engineering and R&D projects, ensuring alignment with organizational objectives and timely completion of deliverables.
• Oversee project management activities, maintaining compliance with quality management systems and regulatory requirements.
• Define project goals, scope, tasks, and resource needs, facilitating effective planning and execution.
• Develop and implement risk mitigation strategies, managing project changes and ensuring adherence to budgets and timelines.
• Direct design and project control efforts, ensuring all activities meet quality and regulatory standards, including ISO and Class 3 requirements.
• Collaborate with cross-functional teams, including scientists, engineers, quality, regulatory, and operations staff, to achieve project milestones.
• Manage and maintain essential documentation such as Design History Files and Device Master Records.
• Communicate project updates and strategies to internal and external stakeholders, including technical presentations and written reports.

Qualifications:

• Minimum 10 years of experience in the medical device industry or a related discipline.
• At least 3 to 5 years of experience managing teams, projects, or project management functions.
• Strong technical writing and presentation skills, with the ability to clearly explain complex technical concepts.
• PhD in a relevant scientific field, or a Master’s/Bachelor’s degree in Science with additional project management and engineering experience.
• Familiarity with ICH/GCP/FDA regulations and guidelines for medical devices.
• Experience with ISO standards, design controls, and test methods for Class 3 medical devices.
• Demonstrated leadership in strategic, operational, and team settings.
• Proven ability to manage budgets, timelines, and cross-functional project teams.

Published Category: Manufacturing & Technical Operations