Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
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:
- MS or BS in Mechanical Engineering, Biomedical Engineering or related discipline.
- Minimum of 5 years’ industry experience in disposable medical device design and development with a focus on technical transfer to commercial manufacturing.
- Experience working with injectable combination products and/or drug products is a plus.
- History of success using 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. Ability to identify critical dimensions and understand impact of changes to form, fit and function.
- Strong understanding of mechanical engineering principles, methods and experience designing and developing sterile, injection molded mechanical assemblies. Experience with bonding, mechanical snaps, needle design, and needle coating technology a plus.
- Knowledge and familiarity with Design Control for medical devices and/or combination products. Working knowledge of 21 CFR 820, ISO 13485.
- Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluate processes and develop practical solutions to technical challenges.
- Knowledge of ISO 11608, ISO 7864, IEC 62366.
- Good interpersonal, communication, data analysis and effective problem-solving skills.
- High degree of initiative and self-motivation.
- Experience creating technical and written content.
- A diligent team-player that is passionate about helping patients and effectively collaborates in a dynamic, cross-functional collaborative environment.
Knowledge/Skill:
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- 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.
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/.
