Senior Engineer, R&D Projects
POSITION PROFILE
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.
Job Duties and 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.
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 are preferred.
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
Technical Expertise:
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.
Skills:
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.
Personal Attributes:
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 @types of environments including typical office and light manufacturing, and within the hospital or clinic.
Minor physical effort is required, which may involve long periods of standing, walking or similar activities.
Some travel may be required (i.e., to conferences and meetings).
Requires strong written and verbal English language skills to communicate with key stakeholders.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.
Come Create at Ricoh:
If you are seeking a team driven by passion and purpose, come create with us at Ricoh. We are a team of information seekers and customer-obsessed collaborators who aspire to deliver the services, solutions, and technologies that empower business success. We are looking for talented, inspired individuals to join us to help drive high-performance team and our commitment to excellence.
Ricoh is an integrated solutions provider and partner that connects people and technology, creates outstanding customer experiences, and delivers innovation for businesses worldwide. We empower digital workplaces by enabling individuals to work smarter from any location and harness the power of information-how it is collected, stored, managed, and shared-to unlock the potential in every organization. We deliver services and technologies that inspire our customers' success and guide them toward a better and more sustainable future. If you are seeking a purpose-driven and passionate team, come create with us, and help drive our high-performance culture of excellence into tomorrow.
Invest in Yourself:
At Ricoh, you can:
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.
