Sr. Engineer, Device Development

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.Position Summary:This position will serve the role of medical device development engineer within Pharmaceutical Development. Experienced engineer who executes technical development of drug delivery medical devices and packaging. The role includes but is not limited to determining design input, generating design outputs, conducting design verification and validation, developing manufacturing and inspection processes, supporting GMP manufacturing of clinical trial material. This individual will execute assigned project activities and work with project team members to develop and manufacture the combination products. They may oversee the execution of project tasks and monitor the activities and deliverables of project aspects in a leadership role. The position is set in a dynamic and fast-paced environment.Critical areas of focus will be mechanical design, testing, risk management activities, technical transfers, scale-up and new process development.Principal Duties and Responsibilities include the following:Design medical device mechanical components and packaging.Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA)Lead design verification and validation (V&V), design outputs (drawings, specs), and feasibility assessments, including prototyping and lab testing.Collaborate with Quality, Regulatory, Human Factors, and Manufacturing teams, often managing relationships with external CMOs/suppliers.Author technical documentation to ensure compliance with FDA, EU, and ISO standardsCommunicate project plans, status updates and progress against milestones to project team members including managementGenerate technical documents including test protocols and reports documenting product and process knowledgeDisplay a strong understanding of product development and transfer needs of commercial developmentQualification Requirements:Minimum of a bachelor’s degree (advanced degree desirable) in Mechanical Engineering, Biomedical Engineering or related discipline8+ years of experience in medical device design, development and testingStrong knowledge and understanding of medical device design controls and product realization processes.Strong knowledge of ISO 13485, ISO 14971, IEC 62366Experience using 3D modeling software such as SolidWorks or ProEngineerCapital project experience, including authoring User Requirement Specifications for processing equipment, vendor proposal selection, design review and Factory Acceptance TestingDemonstrated ability to apply strong fundamental scientific and engineering skills to evaluate processes and develop practical solutions to technical challengesUse of DoE and associated statistical methods for process and design space optimizationDemonstrated written and verbal communication skillsDemonstrated data analysis and problem-solving skillsHigh degree of initiative and self-motivation to meaningfully advance multiple tasks and projectsStrong interpersonal skillsExperience solving ambiguous problemsExperience creating technical, written contentA hard-working, team-player that is passionate about science and can effectively collaborate in a dynamic, cross-functional matrix environmentGeometric Dimensioning and Tolerancing (GD&T) practicesAbility to interpret and draft technical drawings and schematicsExperience designing and developing mechanical assembliesStrong understanding of mechanical engineering principles and methodologiesExperience in plastic part design, extrusion techniques and injection moldingFamiliarity with best practices for implementing automated systems (e.g. GAMP)Drafting of regulatory submission documents and agency audit experienceWorking Conditions:Production Floor – gowning requirementsBendingLiftingSalary Range$140,000—$155,000 USDOcular 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 . For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.