MechanicalPlastics Engineer

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Key Responsibilities Confidential information

Design and develop injection-molded and thermo formed plastic components for use in bioprocessing (e.g. drug substance and drug product manufacturing).

Select appropriate polymers and materials based on biocompatibility extractables/leachables profiles sterilization compatibility and mechanical requirements.

Work closely with cross-functional teams (R&D Manufacturing Quality Regulatory and Supply Chain) to bring new consumables from concept to production.

Define and validate manufacturing processes including tooling design mold flow analysis DFM/DFMA and process qualification (IQ/OQ/PQ).

Support validation activities including material characterization aging studies extractables/leachables and gamma/radiation stability.

Evaluate supplier capabilities and work with vendors for tooling and component manufacturing (especially in India and APAC).

Participate in failure analysis design reviews and continuous improvement initiatives for existing consumables.

Document design control deliverables including specifications drawings risk assessments and test protocols in compliance with ISO 13485 and GMP requirements.

Qualifications Confidential information

Bachelors or Masters degree in Mechanical/Plastics Engineering Polymer Science Mechanical Engineering or a related field.

3 6 years of relevant industry experience in plastic component design and development preferably in medical devices bioprocessing or pharma packaging.

Hands-on experience with CAD tools (e.g. SolidWorks Creo) and mold flow simulation software (e.g. Moldex3D Autodesk Moldflow).

Strong understanding of plastic materials (e.g. PE PP EVA PC PSU TPE silicone) and sterilization methods (gamma autoclave EtO).

Knowledge of relevant standards (USP ISO 10993 ISO 11607 ISO 11137).

Experience with cleanroom manufacturing and regulatory standards (ISO 13485 cGMP) is a strong plus.

Excellent communication problem-solving and project management skills.

Fluent in English; local language skills are a plus.

Key Responsibilities Confidential information Design and develop injection-molded and thermo formed plastic components for use in bioprocessing (e.g. drug substance and drug product manufacturing). Select appropriate polymers and materials based on biocompatibility extractables/leachables pr...