Senior Engineer, R&D Projects

Ricoh • Winston-Salem, NC

3h

About The Position

The Research and Development (R&D) project engineer role is a full-time position with the Ricoh 3D for Healthcare team. 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 the innovation in patient-specific products and solutions, this role focuses on the development of new 3D-printed medical products from concept to commercialization, and contributes directly to intellectual property creation, including patents and proprietary technologies. The role will be based in Winston-Salem, North Carolina.

Requirements

• Bachelor’s degree (or higher) in Biomedical Engineering, Process Engineering, Mechanical Engineering, or a related field.
• Minimum 3-5 years of experience in R&D engineering with a focus on surgical planning tools, 3D-printed solutions, and medical device development.
• Proficiency with 3D modeling and CAD software (i.e., SolidWorks, AutoCAD) and additive manufacturing technologies (i.e., 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 eager 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.
• Requires strong written and verbal English language skills to communicate with key stakeholders.

Nice To Haves

• Advanced degrees or certifications in medical device development and 3D printing technology are preferred.

Responsibilities

• Medical Device Design and Development
• 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, focusing on 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.
• 3D Printing and Prototyping
• Develop and optimize 3D-printed products and solutions (i.e., surgical guides) ensuring precision, biocompatibility, and regulatory compliance.
• Oversee the prototyping, testing, and validation of personalized medical devices using advanced additive manufacturing techniques.
• Market Assessment and Competitive Analysis
• Conduct market research and assessments to understand current industry trends, emerging technologies, and customer needs.
• Perform competitive analysis and benchmarking to position products effectively in the market and inform R&D strategy.
• Work with marketing, sales, and business development teams to identify market opportunities and guide product roadmaps.
• Quality and Regulatory Compliance
• 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.
• Collaboration and Communication
• 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.
• Project Management and Leadership
• 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.

Benefits

• Choose from a broad selection of medical, dental, life, and disability insurance options.
• Contribute to your financial security with Retirement Savings Plan (401K), Health Savings Account (HSA), and Flexible Spending Account (FSA) investments.
• Augment your education with team member tuition assistance programs.
• Enjoy paid vacation time and paid holidays annually
• Tap into many other benefits to enhance your health, wellness, and ongoing personal and professional development.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level