What are the responsibilities and job description for the Manufacturing Engineer position at TekOne IT Services Pvt. Ltd. ?
Process Development & Improvement: Review new design changes for manufacturability and offer feedback. Design process improvements to reduce product cost, shorten cycle time, and enhance product quality. Validation: Write and perform process validations (IQ/OQ/PQ) on equipment as required. Ensure processes and equipment meet standards for performance and safety. Documentation & Compliance: Create documentation to support new or improved manufacturing processes. Ensure compliance with FDA, GMP, MDD, and ISO regulations. Equipment & Tooling: Make recommendations for equipment purchases based on manufacturing needs. Perform experiments (including Design of Experiments (DOE)) to improve processes. Quality & Issue Resolution: Handle Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs). Identify and resolve issues affecting product quality or manufacturing efficiency. Collaboration: Work closely with manufacturing teams, supervisors, and engineers to interpret design intent and improve processes. Coordinate with suppliers and external resources to develop and implement new processes. Facilitate effective communication between team members and management. Safety & Regulatory Compliance: Ensure all personal and company operations comply with Federal, State, and local regulations. Monitor subordinates' adherence to Health, Safety, and Environmental practices. Required Skills And Qualifications Education: Bachelor's degree in Engineering, Manufacturing, or a related field. Experience: 4 years of relevant work experience, preferably in a medical device manufacturing environment. Expertise in Design for Manufacturing (DFM), Design of Experiments (DOE), and Failure Mode and Effects Analysis (FMEA). Experience working in a fast-paced environment with minimal supervision. Technical Skills: Proficient in Microsoft Office Suite (Word, Excel, Project, Outlook). Understanding of FDA, GMP, MDD, and ISO regulations. Strong Lean Manufacturing background preferred. Soft Skills: Strong written, verbal, and interpersonal skills to interact effectively with all levels of employees and management. Ability to multitask and manage multiple priorities. Preferred Qualifications Experience in Lean Manufacturing methodologies. Hands-on experience with regulatory standards in the medical device industry. Strong background in process optimization and continuous improvement.
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