Engineer III, Device Development

Engineer III, Device Development

Position Summary :

We are seeking an experienced and motivated engineer to support the Device Development Team within Pharmaceutical Development in the commercial development and manufacturing of an intravitreal injector to deliver a sustained release implant for use in the treatment of retinal diseases. Key responsibilities include product design (CAD modeling), design verification, design validation and other elements of medical device Design Control. The role includes process development activities, line layout, fixture design, equipment procurement, and partnering with contract manufacturing organizations in support of GMP injector manufacturing.

This individual will help define product and material specifications, design and development plans, conduct detailed design analysis, design for manufacture / assembly, selection of lubricious coatings, and other development objectives. This role requires collaboration across internal and external partners to ensure integration of the drug and device constituents of the combination products.

Areas of focus include CAD design and maintenance of engineering drawings, Design for Manufacturability, process development and incorporation of fixture design and semi-automated processes to support development of manufacturing processes for late-stage clinical production that are capable, scalable, and sufficiently robust for transfer to commercial manufacturing.

Principal Duties and Responsibilities include the following :

• Apply sound engineering problem-solving techniques to product design development including technology assessments, concept generation, material selection, functionality and performance for novel drug delivery device products.
• Provide hands-on design, CAD renditions, prototype fabrication for new injectable products (i.e. device constituent part of combination product).
• Design, procure and / or fabricate jigs, fixtures, semi-automated tooling and processes to assist with the manufacturing assembly of combination products.
• Develop product specifications, material specifications, identify critical to quality material attributes, design assemblies.
• Develop test methods and conduct bench-top testing to evaluate finished devices.
• Participate in design control activities, including user requirements, product specifications, DFMEA, design verification and validation.
• Support cGMP manufacturing of investigational product to support Phase III clinical studies.
• Develop scalable manufacturing processes for critical attribute, process parameter control, and design tolerance using a QbD approach.
• Communicate study design, data analysis and results to technical team members.
• Communicate project plans, status updates and progress against milestones while working in collaboration with the device development group and project team members including management.

Qualification Requirements :

Knowledge / Skill :