Sr. Manager, Device Manufacturing

Position Summary: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 Contract Manufacturing Organizations (CMOs) to ensure robust, compliant, and efficient production of high-quality devices. The ideal candidate will have extensive experience manufacturing combination products, manage external contract organizations, and oversee tech transfer and commercialization. This position is onsite and reports directly to the Director of Device Development. Principal Duties and Responsibilities include the following: Supporting Existing Suppliers Own and manage critical key supplier relationships and drive supplier performance excellence. Implement strategies for the continuous improvement of commercial products and lifecycle management activities. Coordinate technical and quality groups to deploy engineering support with our 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/or other technical challenges. Support external partner supply planning. Proactively identify component or raw material obsolescence issues and establish appropriate mitigation plans. Generate parameters and reactionary plans associated with statistical process control methods. Collaborate with R&D and Quality to address process performance issues and support. Managing New Suppliers 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 in relation to DFMA improvements. Generate User Requirement Specifications to generate 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 scaleup. Other Duties and Responsibilities: Support recruitment efforts and mentorship of engineering team. Review departmental documentation (e.g., Standard Operating Procedures, Work Instructions, etc.). 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 mitigations 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%) Qualification Requirements: Education and Experience Undergraduate degree in Mechanical, Biomedical, or Manufacturing Engineering; post-graduate degree preferred. 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 in ophthalmic products a plus. Technical Competencies Knowledge of injection molding process, parameters, and best practices. Knowledge of relevant regulations, such as 21 CFR 820, USP, ISO, and FDA Proficiency with SolidWorks or comparable CAD software. Familiarity with GAMP 5 guidelines. Lean Six Sigma training or certification and knowledge of statistical data analysis techniques. Professional Skills Strong interpersonal, verbal, and written communication Excellent organizational skills, attention to detail, and proven project management capability. Computer literacy, proficiency in MS Office, Excel, PowerPoint, Project, Salary Range$172,000—$187,000 USD