mechanical/plastics engineer.

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• Bachelor’s or Master’s 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. 

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