Principal Engineer, Device Development

Position Summary The Principal Medical Device Engineer is a highly experienced and strategic leader in coordinating the ideation, assessment, and development of drug delivery technologies and medical devices. This role focuses on long-term technical vision, innovation, and team leadership while also remaining hands-on with complex technical challenges. The engineer is responsible for managing projects, ensuring compliance, and contributing to the overall success of the company's medical device portfolio. Principal Duties And Responsibilities Include The Following Leads the design and development of new or improved medical devices, ensuring they meet regulatory requirements, quality standards, and user needs. Ensure high-quality science, technology, and deliverables while ensuring compliance with global regulatory and quality requirements to support development and lifecycle management of Ocular drug delivery systems. Oversees design verification testing and validation of prototypes and final products to ensure safety, effectiveness, and performance. Operates with a high degree of autonomy to lead and conduct research and development activities to invent/improve drug delivery systems, with direct input to strategic decision-making. Mentors and guides junior engineers, providing technical direction and support. Manages project timelines, budgets, and resources to ensure timely and cost-effective delivery of medical devices. Research device clinical use, standards, and other relevant regulatory guidance documents to support new product development and regulatory submissions with compliance to governing procedures, 21CFR 820.30 Design Control, CFR Part 4 Combination Products, and

ISO 14971

Risk Management for medical devices and/or combination products. Assist in writing IND/NDA regulatory responses as needed. Identifies and explores new technologies and materials for medical device development. Collaborates with various teams, including manufacturing, marketing, and other product stakeholders to develop design requirements and ensure product success. Identifies and resolves technical issues, ensuring product quality and performance. Analyzes data from testing, research, and manufacturing processes to identify trends and areas for improvement. Develops and implements change management plans for existing products, ensuring compliance and minimizing disruption. Partner with other functions, including Manufacturing, Safety/Clinical, Human Factors, Quality, Regulatory, and Design Engineering, to lead and perform risk assessments. Qualification Requirements Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering or a related field. 15+ years of experience in medical device design, development, and testing. 5+ years of experience with combination product development (injectable or ophthalmic products preferred). Experience with all phases of product development from initial concept through commercialization. Experience in third party management (manufacturers, labs, and consultants) Experience creating, maintaining, and remediating Design History Files (DHFs) and ensuring compliance with regulatory requirements for parenteral combination products is preferred (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366). Experience mentoring and guiding junior engineers; leading other engineering disciplines to execute and overcome product development technical challenges. Experience with Project Management, Gantt Charts, (PMP certification a plus). Experience with CAD software, drafting standards, materials science, and tolerance analysis. Prior experience with generating human factors deliverables to comply with IEC 62366 and FDA Human Factor guidance. Strong communication, leadership, problem-solving, and collaboration skills are essential. Experience developing and implementing new testing methods for medical devices to ensure safety and effectiveness. Experience conducting Measurement System Analysis. Experience performing a risk assessment on a new medical device and developing mitigation strategies. Knowledge of ISO 14971 and FMEA standards. Experience conducting user risk assessments. Experience with statistical techniques used in product development as well as manufacturing. Six Sigma Greenbelt or equivalent a plus.