02 Aug
|
Olympus
|
Secunderabad
02 Aug
Olympus
Secunderabad
About Olympus
We are an equal opportunities employer and we are committed to ensuring that no applicant or employee receives less favorable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements which cannot be shown.
The job is conducted in line with our Core Values which are: Patient Focus, Integrity, Innovation, Impact and Empathy. Olympus is an equal opportunities employer championing a culture of equality, diversity and inclusion embedded throughout the organization and workforce.
Purpose of the Role:
The Material Science SME will provide deep technical expertise in the selection, justification, evaluation, and risk assessment of engineering materials used in medical-device product development and lifecycle management.
The role is expected to support New Product Development, sustaining engineering, CAPA, cost reduction, supplier change, localization, component redesign, manufacturing-process changes, and failure investigations. The SME will help teams make evidence-based material decisions for plastics, metals, elastomers, coatings, adhesives, and surface treatments used in medical-device assemblies.
The Material Science SME will serve as the technical authority for material selection and compatibility, ensuring that chosen materials are appropriate for the intended product function, manufacturing process, use setting, chemical exposure, cleaning/reprocessing conditions, sterilization method, durability expectations, regulatory requirements, and supplier/manufacturer capability.
This role will also support the creation of technical justifications, material evaluation reports, risk assessments, DFMEA inputs, CAPA investigation reports, design-control documentation, and supplier/material qualification strategies.
Key Responsibilities:
Material Selection and Justification
Recommend appropriate materials for medical-device components, including plastics, metals, elastomer, coatings, adhesives, and surface treatments.
Justify material choice based on mechanical performance, chemical resistance, wear and friction behavior, thermal/humidity exposure, sterilization or cleaning compatibility, manufacturability, cost, supplier availability, regulatory and risk impact. Suggest suitable grades, alternate grades, and preferred manufacturers.
Prepare material selection reports, comparison matrices, and technical justifications.
Support for NPD Support concept and detailed design reviews with material recommendations. Help mechanical engineers select materials suitable for the intended function and manufacturing process. Define material evaluation and test requirements for prototypes and design iterations. Support TRL/feasibility activities with material risk assessment and manufacturability input. Provide inputs to drawings, specifications, BOMs, DFMEA, and design documentation.
Support for Sustaining Engineering
- Assess alternate materials for obsolescence, cost reduction, supplier change, localization, or performance improvement. Evaluate equivalency between existing and proposed materials.
- Assess impact of material changes on performance, safety, durability, manufacturing, cleaning/sterilization, and regulatory documentation. Support engineering change requests with material justification and risk assessment.
CAPA and Failure Investigation Support
- Support CAPA investigations involving material-related failures such as:
- Cracking, corrosion, creep, fatigue, wear, discoloration, swelling, adhesive or coating failure, environmental stress cracking.
- Recommend suitable analysis methods such as microscopy, SEM/EDS, hardness testing, tensile testing, corrosion testing, chemical exposure testing etc
- Interpret test results and support root cause analysis, corrective actions, and risk updates.
Chemical and Process Compatibility
- Assess compatibility of materials with: cleaning agents, disinfectants, sterilants, bodily fluids, lubricants, adhesives, operating temperature and humidity
Evaluate material suitability for processes such as:
- Injection molding, machining, extrusion, forming, welding, bonding, coating, plating, rapid prototyping.
- Support DFM/DFA by identifying material-process risks such as warpage, shrinkage, residual stress, weld lines, corrosion, burrs, and dimensional instability.
Risk, Quality, and Documentation
- Provide material inputs to DFMEA, PFMEA, hazard analysis, and risk management documentation.
- Support design-control documentation for material selection, material changes, and verification planning.
- Review supplier datasheets, certificates, regulatory statements, and material compliance documents.
- Maintain a preferred material/grade knowledge base for recurring use across projects.
Person Specification:
Education
- Bachelor's or Master's degree in Materials Science, Metallurgy, Polymer Engineering, Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline.
- Advanced degree or specialization in polymers, metals, biomaterials, or failure analysis is preferred.
Experience
- 8–12 years of experience in materials engineering, product development, sustaining engineering, or failure analysis.
- Medical-device experience is strongly preferred.
- Experience with plastics, metals, elastomers, coatings, adhesives, and manufacturing processes.
- Experience supporting NPD, CAPA, supplier/material changes, and cost-reduction projects.
- Experience working with global R&D;, quality, regulatory, procurement, manufacturing, external labs, and suppliers.
- Proven experience resolving complex or ambiguous compliance scenarios with clear, documented technical justification.
- Demonstrated experience engaging, educating, and influencing suppliers on regulatory compliance and material disclosure requirements.
- Experience collaborating cross-functionally with R&D;, QARA, Supply Chain, Procurement, and Suppliers.
- Experience mentoring or providing technical leadership to junior engineers or compliance analysts.
- Working knowledge of medical device quality systems including ISO 13485 and MDR Annex I chemical safety requirements.
- Experience working in a global or international business environment, supporting multiple regions and stakeholders preferred.
Skills
- Strong technical background in R&D; engineering disciplines.
- Strong understanding of engineering plastics, metals, elastomers, coatings, adhesives, and surface treatments.
- Ability to recommend suitable material grades and manufacturers.
- Knowledge of chemical compatibility, sterilization/cleaning impact, aging, corrosion, creep, fatigue, wear, and environmental degradation.
- Understanding injection molding, machining, forming, bonding, welding, coating, plating, and rapid prototyping.
- Familiarity with medical-device design controls, DFMEA, ISO 14971-style risk management, CAPA, and engineering change control.
- Strong technical writing, documentation, and cross-functional communication skills.
📌 Material Science Subject Matter Expert Medical Devices (Secunderabad)
🏢 Olympus
📍 Secunderabad