Device Engineer

Gaithersburg, MD, US
Posted 2 months ago by FPC Atlanta

Job Description

We are one of the world’s premier biotechnology companies, and we are industry-leading in immunology, protein engineering and translational science. Our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. We are seeking a Device Engineer that will manage device aspects of projects to achieve project targets in a timely fashion and to agreed quality standards, e.g. plan and review work to ensure that agreed objectives, timescales and budgets are met.

• Take responsibility for the design and development aspects of new device development projects and be proactive in proposing new ideas and solving problems.

• Assess and report data with a clear understanding of its reliability interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated.

• Establish and maintain a close working relationship with suppliers and design consultants and contribute to management of external collaborations.

• Liaise effectively with internal departments (International Marketing, Regulatory Affairs, Product Development, Operations, etc.) to ensure that the proposed design meets their requirements and expectations.

• Oversee the transfer of projects to Commercial Manufacturing. Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP and safety requirements.

• Prepare and maintain documentation and formal reports in accordance with these standards.

• Prepare formal reports and contributions to regulatory documentation.

• Supervise staff and contribute to the training and development of less experienced personnel by acting as coach/mentor as appropriate.

• Experience with the development of devices for biotechnology compounds would be a distinct advantage.

The ideal candidate will have at least a B.S. in Engineering or related discipline

Contact: John Lonon

Recruiters Details

Gaithersburg, MD, US
Job number:
John Lonon
Posted At:
2 months ago
Job Function:
Product Development
Medical Devices & Diagnostics