R&D Scientist

SDI Limited; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

SDI Limited, located near Melbourne, seeks an R&D Scientist (Level 2) to independently plan and execute development projects for dental restorative and cosmetic products, translating design inputs into robust prototypes and manufacturing-ready processes under ISO13485.

You will contribute to SDI strategic priorities, maintain quality compliance, and collaborate with Quality and Manufacturing to define processes, support design transfer, and prepare risk assessments and technical reports in a

Qualifications

• Strong understanding of regulatory obligations for medical devices (MDR, MDSAP, FDA, HC, ANVISA, TGA).
• Solid knowledge of GMP/GDP/GLP principles.
• Degree qualification in science or engineering; professional membership is a plus.

Responsibilities

• Develop and optimise formulations for R&D projects.
• Test, characterise and improve test methods for developmental and final products.
• Analyse data and generate technical reports with conclusions and recommendations.
• Produce and review ISO13485-ready documentation: protocols, reports, batch records, IFU inputs, stability study plans.

Skills

Medical device regulation

GMP/GDP/GLP

Clinical workflows understanding

Quality management systems

Education

Science/Engineering degree

Job description

Company We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.

Summary of Role

The R&D Scientist (Level 2) is responsible for:

• Independently planning and executing research and development projects for dental restorative and cosmetic products, translating design inputs into robust prototypes, validated test methods, and manufacturing-ready processes under the ISO13485 quality system.
• Contributing towards SDI Strategic Priorities.
• Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and innovation.

Specific Responsibilities

• Develop and optimise formulations for research and development projects.
• Test, characterise and improve test methods for existing, developmental (MRL1-6), in-process (MRL7-8), and final (MRL9-10) products.
• Analyse data and generate technical reports with conclusions and recommendations.
• Produce and review ISO13485-ready documentation; protocols, reports, batch records, IFU inputs, and stability study plans. Contribute to risk management and biocompatibility planning.
• Proactively apply, maintain, and support relevant methods, standards, policies and procedures related to SDI's Quality Management System, GMP/GLP, and medical devices' regulatory and legal obligations.
• Partner with Quality and Manufacturing to define processes for both existing and development projects. Support pilot builds and design transfer; author/review work instructions and acceptance criteria.
• Provide domain expertise to assist with root-cause investigations, non-conformance reports, and corrective/preventative actions.
• Maintain compliance with Occupational Health and Safety legislation and contribute to OHS and ESG initiatives at SDI.
• Proactively identify, assess, analyse, and manage risks associated with areas of responsibility and expertise.
• Other activities as requested by SDI Management.

Key Relationships

External - Equipment suppliers, contract laboratories, and research organisations.

Internal - R&D Leadership Team, staff, and Department Managers especially in QC/QA, Production, Engineering, and Marketing

Job Environment

• The position is located at Bayswater or Montrose.
• Working hours: 10-day fortnight.
• Occasional local and interstate travel as required.

Essential Qualification/ Experience

• Strong understanding of medical devices' regulatory and legal obligations such as the MDR, MDSAP, FDA, HC, ANVISA, TGA etc.
• Strong knowledge of GMP/GDP/GLP principles.
• Degree qualification(s) in a role-specific area of science and/or engineering. (E.g. Chemistry, Physics, Materials / Chemical / Biomedical Engineering, etc.) Note: Competencies should match professional membership (e.g. MIEAust, MRACI). Chartership (e.g. CPEng, CChem, CMatP) is advantageous but not essential.
• Proficient understanding of dental clinical workflows of key categories
• Typically, 3-5 years relevant experience, significant projects/technologies, or PhD/post-doc equivalent.

Essential Skills, Knowledge and Attributes

Personal Qualities

Interpersonal skills, teamwork, and team-building capabilities.

An innovation and entrepreneurial mindset - willingness to make business cases and bring ideas to market.

Curiosity - interested in continuing exploration and development.

Proactivity - highly self-motivated to initiate with appropriate approvals.

Knowledge and Skills

• Aware of SDI's current Quality policy and objectives
• Understanding of both competitors' and SDI products, SDI manufacturing processes and systems.
• Commercial understanding, basic clinical knowledge, and strong customer focus.
• Strong organisational skills including the ability to meet deadlines and prioritise project tasks for optimum productivity.
• Excellent communication and presentation skills, including the ability to present highly technical information effectively to "non-scientific" audiences when required.
• Demonstrated resourcefulness in solving technical problems.
• The ability to facilitate teamwork and provide coaching, mentoring, expert technical advice and research inspiration to other scientists.
• Excellent technical report-writing and presentation skills.

Desired Skills and Experience

• Strong understanding of medical devices' regulatory and legal obligations such as the MDR, MDSAP, FDA, HC, ANVISA, TGA etc.
• Strong knowledge of GMP/GDP/GLP principles.
• Degree qualification(s) in a role-specific area of science and/or engineering. (E.g. Chemistry, Physics, Materials / Chemical / Biomedical Engineering, etc.) Note: Competencies should match professional membership (e.g. MIEAust, MRACI). Chartership (e.g. CPEng, CChem, CMatP) is advantageous but not essential.
• Proficient understanding of dental clinical workflows of key categories
• Typically, 3-5 years relevant experience, significant projects/technologies, or PhD/post-doc equivalent; or
• A graduate.