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
• Master’s degree (MSc/MEng) strongly preferred
• Postgraduate specialisation in Chemistry/Chemical Engineering advantageous
• Experience in scientific technical/academic writing
• Experience in medical device or pharmaceutical development, manufacturing, or regulatory environments is advantageous, but not required.

 Independence

• Able to work with minimal supervision after onboarding
• Takes ownership of tasks and solves problems independently
• Proactively identifies knowledge gaps and self-learns to close them

 Problem-solving and critical thinking

• Strong analytical and troubleshooting ability
• Can break down complex or ambiguous problems into clear action steps
• Able to propose solutions and alternatives without being prompted

 Multi-tasking and organisation

• Able to manage several projects at the same time
• Comfortable shifting between priorities as needed
• Strong organisational and time-management skills

 Learning attitude and curiosity

• Eager to learn new systems, regulations, technologies, and scientific concepts
• Comfortable reading, researching, and understanding background material independently

 Behaviour and work ethic

• Proactive, self-motivated, and accountable
• Resilient under pressure and able to make progress despite uncertainty
• High attention to detail, integrity, and professionalism

 Communication

• Strong written communication skills, especially for technical/scientific writing
• Able to communicate effectively across departments
• Fluent in English (written and verbal)