Research and Development Scientist-Engineer

Responsibilities include supporting end-to-end product development (formulation, design controls, validation, documentation, and transfer to production) as well as maintaining existing products to ensure quality, stability, safety, and regulatory compliance in a GMP/ISO 13485 environment. The role involves both collaboration with internal teams and independently managing workstreams.

Independent research and product development:

• Plan, design, execute, and troubleshoot experiments
• Conduct literature reviews and self-directed research to support product development
• Lead the development, optimisation, and validation of formulations, test methods, and processes
• Manage multiple tasks and long-term development projects simultaneously

Technical problem-solving and process support

• Solve complex technical challenges affecting formulations or manufacturing
• Support and improve production processes and resolve raw material or process-related issues
• Perform material acceptance, supplier evaluations, and introduce new materials/equipment as needed
• Perform data trending, technical assessments, and stability evaluations

Quality, compliance and documentation

• Maintain accurate, complete technical documentation in line with QMS requirements
• Participate in product risk management activities, including hazard identification, assessment, and mitigation
• Ensure controlled documents (procedures, forms, lists) remain accurate and updated
• Support nonconformity investigations and CAPA activities

Regulatory responsibilities

• Compile complete dossiers for new products (Technical Files, Design Files, Clinical Evaluation inputs, Biocompatibility inputs) per international standards
• Ensure existing product dossiers remain updated and aligned with regulatory requirements
• Support CE marking, SAHPRA submissions, and international regulatory activities
• Ensure labelling, IFUs, and end-user information are compliant and current
• Support PMS/PMCF activities

Cross-functional and external support

• Provide technical input to Quality, Production, and Procurement teams
• Assist with technical and scientific client queries
• Train and support staff on testing equipment and technical processes

REQUIREMENTS:

• Tertiary degree in Science or Engineering
• Masters degree (MSc/MEng) strongly preferred
• Postgraduate specialisation in Chemistry/Chemical Engineering advantageous
• Experience in scientific technical/academic writing
• Experience in medical device or pharmaceutical deve
  
  https://www.jobplacements.com/Jobs/R/Research-and-Development-Scientist-Engineer-1240480-Job-Search-11-19-2025-6-58-36-AM.asp?sid=gumtree