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.