Senior Engineer, R&D Projects

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