Manufacturing Engineer II

About INOVIO

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.

Job summary

The temporary Manufacturing Engineer II assists in developing and improving manufacturing processes, techniques and procedures associated with building, packaging, labeling and maintaining medical devices (electromechanical and sterile disposable) used in ongoing clinical trials. The tasks are completed by the temporary Manufacturing Engineer II with a steady focus on continuous improvement of product quality through leaner concepts and activities.

Essential job functions and duties

• Create drawings and models in SolidWorks.
• Design, implement and troubleshoot manufacturing tooling and fixtures with minimal to moderate supervision.
• Design and implement product packaging and labeling per applicable standards and regulatory requirements.
• Implement new and revised product and packaging documentation through Change Control System.
• Verify, validate and document product designs with minimal to moderate supervision.
• Work with Sr. Manufacturing Engineers to help develop new processes and procedures for new and existing product lines.
• Support manufacturing, process validation, development, and product research efforts.
• With some supervision, create and revise Manufacturing and Testing Work Instructions including visual aids, Specifications, Inspection and Qualification Documentation.
• Perform equipment Qualification/Validation.
• Investigate and report manufacturing issues, failures and non-conformances. Support Quality System Technical Compliance with participation in Material Review Board, Non-Conforming Material Investigations and Corrective and Preventative Action (CAPA) activities.
• Solve production related problems and document solutions.
• Participate in design reviews as needed.
• Follow processes and procedures for supporting and developing products.
• Provide engineering support for other departments and other Manufacturing Engineering duties as necessary.

Minimum requirements

• Bachelor's degree in manufacturing or mechanical engineering (BSME).
• Minimum 2 years of engineering experience required; experience in medical device industry preferred.
• SolidWorks experience required.
• Ability to create components, assemblies, and drawings.
• Technical writing experience is preferred.
• Highly experienced user of Microsoft Office Suite to create documentation, spreadsheets, and databases to support Manufacturing operations.