Scientist
Job Title: Scientist
Location: NC
Duration: 8 Months
Key Responsibilities:
- Design, execute, and analyze experiments to support product development, process optimization, and verification/validation activities.
- Conduct feasibility, biocompatibility, and stability studies for new and existing medical devices.
- Collaborate with cross-functional teams including Engineering, Regulatory Affairs, and Quality Assurance to ensure alignment with product development goals and compliance requirements.
- Prepare and review scientific documentation including study protocols, technical reports, risk assessments, and design history files (DHFs).
- Develop and validate analytical test methods (e.g., HPLC, GC, FTIR, mechanical testing, etc.) as needed for device materials and components.
- Participate in root cause analysis, non-conformance investigations, and CAPA implementation.
- Ensure compliance with relevant regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 10993, etc.).
- Maintain laboratory records and follow Good Laboratory Practices (GLP).
- Support regulatory submissions (e.g., 510(k), PMA) by providing scientific data and justifications.
- Monitor industry trends, emerging technologies, and regulatory changes relevant to medical devices.
Qualifications:
- Education: BS or MS or PhD in Biomedical Engineering, Material Science, Chemistry, Biology, or a related field.
- Experience: 2-8+ years of experience in a scientific or technical role within the medical device, pharmaceutical, or biotech industry.
- Hands-on experience with analytical instrumentation and data interpretation.
- Familiarity with design controls, risk management, and product lifecycle in a regulated environment.
- Knowledge of relevant standards (ISO 13485, ISO 10993, ISO 14971) and FDA QSRs.
- Strong written and verbal communication skills.
- Ability to work independently and within multidisciplinary teams.
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