What are the responsibilities and job description for the Engineer I, Device Development position at Ocular Therapeutix?
Position Summary :
We are seeking a 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. The role includes but is not limited to product design (CAD modeling), design verification testing, and other elements of medical device Design Control. This individual will execute assigned project activities and work with project team members to develop and manufacture the injector.
Primary areas of focus will be conducting detailed design analysis, CAD design, product testing, packaging evaluations, 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.
Principal Duties and Responsibilities include the following :
- Apply sound engineering problem-solving techniques to product development including concept generation, material selection, functionality and performance for novel drug delivery device products.
- Develop test methods and conduct bench-top testing to evaluate finished devices. Work with contract laboratories as needed to execute testing.
- Communicate project status, data analysis and plans to project team members including management
- Generate technical documents including protocols and reports summarizing experimental plans and test results
- 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.
- Assist in developing product specifications, material specifications, identify critical to quality material attributes, design assemblies.
- 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.
- Other duties as assigned
Qualification Requirements :
Knowledge / Skill :
Working Conditions :
