Engineer I, Device Development

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:

1. Apply sound engineering problem-solving techniques to product development including concept generation, material selection, functionality and performance for novel drug delivery device products.
2. Develop test methods and conduct bench-top testing to evaluate finished devices. Work with contract laboratories as needed to execute testing.
3. Communicate project status, data analysis and plans to project team members including management
4. Generate technical documents including protocols and reports summarizing experimental plans and test results
5. Provide hands-on design, CAD renditions, prototype fabrication for new injectable products (i.e. device constituent part of combination product).
6. Design, procure and/or fabricate jigs, fixtures, semi-automated tooling and processes to assist with the manufacturing assembly of combination products.
7. Assist in developing product specifications, material specifications, identify critical to quality material attributes, design assemblies.
8. Participate in design control activities, including user requirements, product specifications, DFMEA, design verification and validation.
9. Support cGMP manufacturing of investigational product to support Phase III clinical studies.
10. Other duties as assigned

Qualification Requirements:

• MS or BS in Mechanical Engineering, Biomedical Engineering or related discipline.
• Minimum of 0-3 year industry experience in disposable medical device design and development. Experience with injectable combination products and/or drug products is a plus.
• Experience with 3D modeling software such as SolidWorks in the design of disposable plastic products and assembly fixtures. SolidWorks CAD certifications a plus.
• Ability to interpret and draft technical drawings and schematics following sound Geometric Dimensioning and Tolerancing (GD&T ASME Y14.5) practices.
• Experience in designing, executing, analyzing, and reporting on experiments/product testing. Able to use statistical software such as JMP, Minitab to design experiments a plus.
• Familiarity Design Control standards 21 CFR 820 and ISO 13485. Knowledge of ISO 11608, ISO 7864, IEC 62366 a plus.
• Good interpersonal, communication, data analysis and effective problem-solving skills.
• High degree of initiative and self-motivation.
• Experience creating technical and written content in a FDA regulated environment.
• A diligent team-player that is passionate about helping patients and effectively collaborates in a dynamic, cross-functional collaborative environment.

Knowledge/Skill:

• • Knowledge of medical device and/or pharmaceutical product development practices and regulatory requirements.
  • Good communication, data analysis and effective problem-solving skills.
  • Knowledge of safe laboratory practices.
  • Able to drive work and tasks to completion.
  • Excellent multi-tasking and prioritization skills.
  • Friendly interpersonal skills.

Working Conditions:

• Office environment
• Laboratory and environmentally controlled GMP environment.
• Limited travel to contract manufacturing sites when necessary.
• Bending, lifting (<25 lbs)