Overview

Job Summary Responsible for leading complex product design initiatives within cross-functional development teams. This role involves researching, designing, and prototyping innovative medical devices, translating user needs into design specifications, and ensuring compliance with regulatory standards. The Senior Design Engineer provides technical expertise, mentors junior engineers, and drives design excellence throughout the product development lifecycle, contributing to successful product launches and continuous improvement efforts. Job Description Responsibilities: Lead product design efforts by developing CAD models, prototypes, and technical documentation that meet design inputs and regulatory requirements. Utilize engineering tools such as SolidWorks and other CAD software to produce 3D models, PCB layouts, and design documentation in accordance with internal standards and regulatory requirements. Guide cross-functional collaboration with product management, clinical, regulatory, and quality teams to define user needs and translate them into actionable design specifications. Drive design transfer activities, ensuring smooth transition from R&D to manufacturing through validation builds, process development, and troubleshooting. Support intellectual property strategy by identifying novel design concepts and partnering with legal to secure patents. Mentor junior engineers and contribute to design reviews, fostering a culture of technical excellence and continuous improvement. Integrate human factors and user centered design philosophies into product development to enhance safety, effectiveness, and user satisfaction. Lead multi-disciplinary product development teams to research, design, and develop new products and technologies. Ensure product designs meet all design specifications. Manage multiple projects by coordinating timelines, resources, and priorities to meet development milestones and business objectives. Evaluate and improve existing products through root cause analysis, risk assessments, and feedback from users, manufacturers, and post-market surveillance. Contribute to innovation pipelines by collaborating with product divisions to identify new product opportunities, and align product design efforts with long-term strategic goals. Qualifications: Education Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or related technical field. Work Experience Minimum of 4 years of experience in product design, preferably within a regulated industry such as medical devices. Advanced proficiency in SolidWorks or equivalent 3D CAD software, including experience with prototype development, design documentation, and design for manufacturability. Demonstrated experience working within a structured product development process, including exposure to design controls, risk management, and cross-functional collaboration. Preferred Qualifications: Certification / Licensure Certified Solidworks Professional certification. Work Experience Experience in product design within the medical device industry, including development and launch of Class II devices. Strong understanding of design controls, risk management (e.g., FMEA), and regulatory documentation (e.g., DHF, DMR, traceability matrices). Experience designing and launching class II medical device to market, including managing develpment timelines and milestones. Recognized contributor to intellectual property Knowledge / Skills / Abilities Position requires travel up to 10% of the time for business purposes (domestic and international). Strong working knowledge of manufacturing processes such as injection molding, machining, and assembly techniques relevant to medical devices. Strong analytical and problem-solving skills, with the ability to troubleshoot complex design and manufacturing issues. Familiarity with regulatory standards including FDA 21 CFR Part 820, ISO 13485, and ISO 14971. Effective communication and collaboration skills, w