The Research and Development (R&D) Project Engineer role is a full-time position with Ricoh 3D for Healthcare. The R&D Project Engineer will be responsible for leading and managing projects focused on the design, development, and optimization of surgical planning tools, 3D-printed surgical guides, and related patient-specific medical devices. This role combines technical expertise, project management, and a collaborative approach to support innovation, streamline processes, and create solutions that advance patient care and clinical outcomes.
Driving innovation in patient-specific products and solutions, this role focuses on the development of new 3D-printed medical products from concept to commercialization, contributing directly to intellectual property creation, including patents and proprietary technologies. The position will be based in Winston-Salem, North Carolina.
Job Duties and Responsibilities Apply engineering principles to design, analyze, and refine medical devices, focusing on usability, safety, and regulatory standards. Design and develop innovative solutions for pre-operative planning, emphasizing accuracy, patient-specific considerations, and clinical effectiveness. Execute all phases of Design Control, including requirement generation, specification development, risk analyses, performance testing, and design reviews in alignment with FDA and ISO 13485 requirements. Develop and optimize 3D-printed products and solutions (e.g., surgical guides), ensuring precision, biocompatibility, and regulatory compliance. Oversee prototyping, testing, and validation of personalized medical devices using advanced additive manufacturing techniques. Conduct market research and assessments to understand industry trends, emerging technologies, and customer needs. Perform competitive analysis and benchmarking to position products effectively in the market and inform R&D strategy. Collaborate with marketing, sales, and business development teams to identify market opportunities and guide product roadmaps. Ensure all processes and designs adhere to relevant regulatory and quality standards, including compliance with ISO 13485 and 21 CFR Part 820, and other applicable guidelines. Work closely with Quality Assurance and Regulatory Affairs teams to develop and maintain technical documentation. Collaborate effectively with internal departments, including manufacturing, marketing, and sales, as well as external partners and clients. Present technical concepts and project status updates to cross-disciplinary teams, including clinicians, engineers, and management. Develop project plans, timelines, and deliverables, coordinating with internal and external stakeholders, including surgeons, regulatory bodies, and manufacturing teams. Mentor junior engineers to support team growth. Qualifications (Education, Experience, and Certifications) Bachelor’s degree (or higher) in Biomedical Engineering, Process Engineering, Mechanical Engineering, or a related field. Advanced degrees or certifications in medical device development and 3D printing technology. Minimum 3-5 years of experience in R&D engineering, with a focus on surgical planning tools, 3D-printed solutions, and medical device development. Knowledge, Skills, and Abilities Proficiency with 3D modeling and CAD software (e.g., SolidWorks, AutoCAD) and additive manufacturing technologies (e.g., extrusion, SLA, SLS, inkjet). Deep understanding of anatomical modeling, image processing, and related medical imaging software. Strong familiarity with regulatory and quality requirements (ISO 13485, FDA 21 CFR 820). Experience in risk management, verification and validation testing, and process development for medical devices. Strong project management, problem-solving, and analytical skills. Excellent verbal and written communication skills, with the ability to convey technical information clearly. Ability to collaborate across disciplines and eagerness to work with healthcare professionals. Detail-oriented and results-driven with a commitment to quality and innovation. Adaptable and responsive to changing project needs and challenges. Passionate about improving healthcare outcomes through technological advancement and collaborative development. Conducting themselves professionally. Completing all training assigned by Ricoh Corporation and the Ricoh 3D team. High level of attention to detail. Natural curiosity and willingness to learn. Working Conditions, Mental and Physical Demands Work is performed in multiple environments, including typical office and light manufacturing settings, as well as in hospitals or clinics. Minor physical effort is required, which may involve long periods of standing, walking, or similar activities. Some travel may be required (e.g., to conferences and meetings). Strong written and verbal communication skills in English are required to interact with key stakeholders.The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the position.