Sr. Manager, Device Manufacturing

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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™.

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.

The Senior Manager of Device Manufacturing is responsible for the technical and operational leadership of combination products manufactured externally during phases of development and commercial production. This critical role involves managing primary and secondary CMO relationships to ensure robust, compliant, and efficient production of high‑quality devices. The ideal candidate will have extensive experience manufacturing combination products, managing external contract organizations, and overseeing tech transfer and commercialization.

This position is onsite and reports directly to the Director of Device Development.

• Own and manage critical key supplier relationships and drive supplier performance excellence.
• Implement strategies for continuous improvement of commercial products and lifecycle management activities.
• Coordinate technical and quality groups to deploy engineering support with partners to understand design issues, improve quality, reliability and overall performance.
• Lead root cause analysis and corrective actions for production issues, post‑market feedback, and other technical challenges.
• Support external partner supply planning.
• Proactively identify component or raw material obsolescence issues and establish appropriate mitigation plans.
• Generate parameters and reactive plans associated with statistical process control methods.
• Collaborate with R&D and Quality to address process performance issues.
• Lead and manage the technical aspects of onboarding a CMO.
• Review and support the generation and execution of supplier contracts (SOWs, MSAs, QAs, SAs).
• Provide technical approval and oversight into the development of fully automated assembly equipment for commercial manufacturing.
• Collaborate with Device Development team to support product changes related to DFMA improvements.
• Generate User Requirement Specifications to enable high‑throughput machinery.
• Oversee process development of new methods in a highly technical and documented manner.
• Provide engineering review and approval of equipment qualifications and process validation (IQ/OQ/PQ), including protocol development, process execution, data analysis, and reporting.
• Review and approve work instructions for proper device manufacturing.
• Collaboratively draft process risk documentation consistent with internal and external risk management guidelines.
• Generate and manage timelines and resourcing needs to support manufacturing scale‑up.

• Support recruitment efforts and mentorship of engineering team.
• Lead cross‑functional teams and effectively influence key stakeholders.
• Open and manage change controls to facilitate product and process improvements.
• Assist with drafting and reviewing documentation prepared for regulatory review and approvals.
• Promptly communicate project progress, risks, and mitigation strategies to the internal project management organization.
• Perform additional tasks as needed to support team and organizational success.
• Travel to manufacturing sites anticipated (10‑20%).

• 10+ years’ experience in medical device or combination products.
• Experience working in a GMP setting.
• Experience with external regulatory inspections (e.g., FDA) a plus.
• Experience manufacturing needle‑based delivery devices.
• Familiarity with ophthalmic products a plus.
• Knowledge of injection molding process, parameters, and best practices.
• Knowledge of relevant regulations, such as 21 CFR 820, USP, ISO, and FDA.
• Proficiency with…