Chemical Engineer – Medical Device

Job Description: Chemical Engineer – Medical Device

Location – Bangalore, Chennai, Hyderabad

Role Overview

An investigative and self-driven Chemical Engineer will support the development, manufacturing, and continuous improvement of medical devices. They will apply expert knowledge in materials, polymers, and chemical processes, including sterilization science and regulatory compliance. They will leverage knowledge of chemical engineering principles while collaborating with product development teams, quality, manufacturing plant operations, and the supply chain organization.

The goal is to ensure products meet safety, performance, and patient safety requirements.

Core Responsibilities

• Improve processes and solve problems by applying technical, mathematical, and scientific principles.
• Propose, implement, review, and correct strategies to ensure that business objectives are met.
• Observe processes and identify ways to enhance efficiency and quality.
• Evaluate products, analyze medical device problems, and solve complex issues.
• Demonstrate proficiency in manufacturing plant operations.

Key Responsibilities

• Understand engineering design issues to properly interpret materials requirements.
• Function as a consultant on materials-related topics for NPD and design changes. Communicate complex chemical and material insights to non-technical teams.
• Support design engineers in formulation development, material selection, chemical risk analysis, and process feasibility. Select and evaluate materials (polymers, elastomers, adhesives, coatings, metals, silicones) suitable for biocompatible medical devices.
• Develop, troubleshoot, and optimize chemico-thermal processes such as extrusion, molding, surface treatment, mixing, bonding, coating, and curing for biocompatible medical device components and materials. Optimize existing manufacturing processes for efficiency, scalability, and cost-effectiveness.
• Apply chemical engineering principles to assess the chemical compatibility of medical device components with drugs, cleaning agents, lubricants, and sterilization methods.
• Provide input for design verification and validation (chemical testing, biocompatibility, aging studies).
• Ensure materials and processes comply with ISO 13485, ISO 10993, ISO 14644, FDA 21 CFR Part 820, and EU MDR requirements.
• Conduct and interpret test reports for FTIR, DSC, TGA, GC-MS, GPC, rheometry, viscosity, and physical/mechanical testing.

Skills

Proficient use of the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).

Strong knowledge of use of Minitab, CAD software, and Mold Flow analysis

Qualifications

Education

BS / MS in Chemical Engineering, Polymer Engineering, Materials Science, or equivalent.

Experience

• 5 - 10 years (customizable) in medical device, pharmaceutical, polymer, or chemical manufacturing preferred; 3-5 years minimum, required.
• Industry experience in a highly regulated environment required.
• Experience with cleanroom manufacturing, medical-grade materials, or process validation preferred.
• Proven experience in process design, scale-up, and manufacturing optimization preferred.
• Knowledge of polymer transformation engineering, surface treatments, and biocompatible materials required.
• Excellent problem-solving, strong verbal/written communication, and project management skills required.