We are seeking a skilled R&D Chemist with a strong background in formulation, chemistry, and chemical engineering to join the dynamic product development team.

Salary range: 90k -110k a year (Based on experience)

Key Responsibilities: R&D Chemist

• Lead the development and optimization of medical lubricants for healthcare applications, including surgical, diagnostic, and therapeutic products.
• Conduct formulation studies to ensure safety, effectiveness, and biocompatibility, optimizing for patient safety and regulatory compliance.
• Design scalable manufacturing processes to ensure consistent, high-quality production.

Regulatory Compliance (510(k) & PMA):

• Collaborate with regulatory teams to support FDA 510(k) and PMA submissions for medical lubricant products.
• Prepare documentation for regulatory filings, including test protocols and reports.
• Stay updated on FDA regulations, ISO standards, and other relevant medical device guidelines.
• Material & Test Specification Development:
• Work with cross-functional teams to define material specifications and develop testing protocols.
• Lead efforts to assess physical, chemical, and biological properties of lubricants, ensuring biocompatibility and performance.

Formulation & Process Optimization:

• Apply chemical engineering principles to optimize lubricant formulations and manufacturing processes.
• Use Design of Experiments (DOE) and Statistical Process Control (SPC) to refine processes and improve product performance.

Collaboration & Cross-Functional Support:

• Collaborate with R&D, quality assurance, clinical, and manufacturing teams to ensure successful product development and commercialization.
• Provide technical expertise and support throughout the product lifecycle.

Documentation & Reporting:

• Prepare detailed documentation, including formulation reports, test protocols, technical specifications, and regulatory submissions.
• Ensure compliance with Good Documentation Practices (GDP) and relevant regulatory standards.

Design Control & Product Lifecycle:

• Manage the design and development lifecycle, ensuring compliance with design control regulations and successful product launch.
• Support the creation of product requirements, design verification, and validation activities.

Qualifications: R&D Chemist

• Bachelor’s or master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related field.
• Experience in formulation design, particularly for medical devices, is required.
• 2-6 years of experience in formulation development or chemical engineering within the medical device or pharmaceutical industries.
• Hands-on experience with medical lubricant formulations and biocompatibility testing is preferred.
• Experience supporting FDA 510(k) or PMA approvals is highly desired.
• In-depth knowledge of chemical engineering principles, including fluid dynamics, viscosity, and material compatibility.
• Familiarity with biocompatibility standards (ISO 10993, USP testing) and regulatory requirements (FDA, ISO 13485, GMP).
• Proficiency in Design of Experiments (DOE) and Statistical Process Control (SPC).
• Ability to create material specifications, test protocols, and regulatory documents.
• Proficiency in Microsoft Office and laboratory data management systems.

Preferred Qualifications: R&D Chemist

• Experience with drug/medical device combination products, particularly those involving lubricants.
• Familiarity with international regulations, including European Union Medical Device Regulations.
• Certification in Good Laboratory Practices (GLP) or related quality standards.

Job Type: Full-time

Pay: $90,000.00 - $110,000.00 per year