Research and Development Scientist-Engineer

SUMMARY:
The R&D Scientist/Engineer will independently conduct research, technical investigations, and development activities related to ophthalmic products. The individual must be able to manage tasks, learn proactively, and solve problems with minimal supervision.

POSITION INFO:

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)