Biomaterials R&D Engineer, Orthopedics

Johnson & Johnson • Warsaw, IN

2d • Hybrid

About The Position

The Biomaterials R&D Engineer supports the design and development of complex medical devices, implants, instrumentation, and biomaterial technologies, as well as in-market products throughout their product life cycles. The role applies engineering principles to develop device and biomaterial designs, fabricate prototypes, conduct testing, and solve technical problems. It contributes to development activities from early design through regulatory filing, product launch, commercialization, and post-market surveillance.

Working on cross-functional project teams, the engineer collaborates with project leaders, marketing, manufacturing, quality, regulatory, testing, supply chain, surgeons, and other stakeholders. The role includes understanding clinical issues and customer needs, defining design parameters and inputs, selecting raw materials and suppliers, supporting process development and manufacturing technology identification, and creating design solutions for unmet needs. Materials investigated may include synthetic, animal-derived, or human-derived materials.

The engineer exercises technical judgment in planning and interpreting experiments, develops and executes design verification and validation plans and tests, supports global regulatory registration efforts, and prepares technical reports and recommendations. The position also requires maintaining technical documentation and a laboratory notebook, testing products against quality and safety standards, and occasional work in a Biosafety Level 2 laboratory. Experience in orthopedic biomaterials is preferred.

Requirements

• Bachelor’s degree in Materials Engineering, Biomedical Engineering, Chemical Engineering, or Mechanical Engineering; a master’s degree in one of these fields with fewer years of experience may be suitable.
• Ability to work independently on multiple projects with minimal supervision.
• Strong prioritization and time-management skills.
• Excellent communication skills for presentations and team meetings.
• Proficiency in Microsoft Office, including advanced Excel and PowerPoint skills.
• General laboratory proficiency to conduct scientific investigations and evaluate device performance.
• Ability to formulate materials suitable for implantation and understand analytical characterization of materials.
• Experience or knowledge of mechanical or chemical testing using standard methods such as ISO, ASTM, or USP is described as relevant.

Nice To Haves

• Zero to two years of experience, including internships or co-ops, in design and development of medical devices, mechanical products, or biomechanical systems is preferred.
• Experience in orthopedic biomaterials is preferred.
• Experience in the medical device industry and knowledge of regulatory design controls are desirable.
• Experience in formulation of implant-suitable materials, analytical material characterization, and mechanical or chemical testing to standards such as ISO, ASTM, or USP.

Responsibilities

• Support the design and development of complex medical devices, implants, instrumentation, and biomaterial technologies throughout the product life cycle.
• Develop device or biomaterial designs, fabricate prototypes, perform testing, and solve technical problems.
• Contribute to development of new biomaterials technologies, including product development, regulatory filing, product launch, and commercialization.
• Work with cross-functional team members on design and development, raw material and supplier selection, process development, and identification of manufacturing technologies.
• Investigate synthetic, animal-derived, or human-derived materials to develop biomaterial solutions for unmet needs and portfolio gaps.
• Stay current with industry trends and materials science advancements and contribute to thought leadership and innovation.
• Prepare and present technical reports and research findings, and make recommendations to stakeholders.
• Design, execute, and interpret experiments using technical judgment to solve complex problems.
• Test products to ensure they meet quality and safety standards.
• Maintain a laboratory notebook and other technical documentation according to required guidelines.
• Participate on cross-functional project teams through all phases of product development and design control.
• Assist project leaders with planning and executing projects or portions of projects through launch, commercialization, and post-market surveillance.
• Technically lead small projects with oversight and work with project leaders, core team members, and surgeons to define design inputs.
• Use rapid and conventional prototyping and other available technologies to develop design solutions.
• Document clinical and surgical technique observations to inform design solutions.
• Develop and execute design verification and validation plans and testing.
• Support regulatory processes for global registration efforts.
• Communicate business-related issues or opportunities to the next management level.
• Follow applicable company Health, Safety, and Environmental practices and applicable federal, state, local, and company regulations, policies, and procedures.
• Perform other assigned duties, which may include calibration liaison, equipment preventive maintenance, and RIM.

What This Job Offers

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