Job Description
The R&D Scientist II plays a key role in advancing innovative medical devices based on regenerative technologies. This position combines hands-on laboratory research with product development responsibilities, including experimental design, material characterization, prototype development, and compliance with design control requirements. The scientist will work independently on defined projects, contribute to cross-functional teams, and support the smooth transfer of products into manufacturing. This role bridges early discovery and applied development, requiring both strong scientific skills and practical problem-solving.
Key Responsibilities
• Plan, execute, and analyze laboratory experiments involving biomaterials, regenerative matrices, and medical device components.
• Contribute innovative ideas for new products, testing methods, or process improvements to enhance R&D capabilities.
• Develop, build, and refine prototypes to meet defined specifications and clinical needs.
• Generate accurate technical documentation, reports, and protocols in compliance with FDA, ISO, and Design Control requirements.
• Characterize materials and prototypes using analytical, biochemical, and mechanical testing methods.
• Perform risk assessments, troubleshoot technical issues, and propose solutions to improve product performance or process robustness.
• Support technology transfer from R&D to manufacturing, including process documentation, validation support, and training of personnel.
• Collaborate with cross-functional teams (Manufacturing, Quality, Regulatory, Marketing, and Clinical) to align product development with business and clinical requirements.
• Engage with external consultants, and customers to gather feedback and translate needs into product features.
• Mentor and provide technical guidance to junior staff on laboratory practices, data analysis, and project tasks.
• Present findings and project updates to management, peers, and cross-functional stakeholders.
• Maintain laboratory operations, including equipment calibration, safety compliance, and method updates.
Qualifications
• MS with 1–2 years or BS with 3–5 years in Biomedical Science, Materials Science, Chemistry, or related field.
• Experience in medical device research and development, biomaterials, or regenerative technologies preferred.
• Knowledge of laboratory techniques for material characterization, tissue-derived biomaterials, or device testing.
• Familiarity with Design Controls, GLP/GMP, and ISO standards.
• Proficiency with experimental design, data/statistical analysis, and technical problem-solving.
• Experience with CAD, prototyping tools, or modeling software is a plus.
• Strong organizational skills with the ability to manage multiple studies and projects simultaneously.
• Excellent communications and presentation skills for cross-functional collaboration.
• Demonstrated ability to work independently, manage multiple priorities, and deliver high-quality results.