What are the responsibilities and job description for the Manufacturing Engineer III position at TekOne IT Services Pvt. Ltd.?
Role: Manufacturing Engineer III
Location: Plainsboro, NJ 0853
Key Responsibilities
Location: Plainsboro, NJ 0853
Key Responsibilities
- Remediation Support: Assist in addressing identified gaps in operations and packaging for EU MDR technical files from an engineering standpoint.
- Project Management: Lead and support complex remediation projects that carry potential risks to product and process integrity, ensuring careful design and execution.
- Process Improvement: Conduct evaluations and improvements on existing processes, support the creation of new manufacturing processes, and troubleshoot manufacturing issues.
- Documentation Compliance: Ensure all documentation, drawings, and specifications align with Integra’s procedures and regulatory requirements (US FDA, ISO).
- Coordination and Collaboration: Manage the development of manufacturing process requirements, including specifications, validations, Engineering Change Orders (ECOs), and engineering drawings.
- Process Control: Utilize statistical process control to analyze and trend process parameters, improve yields, reduce scrap, and enhance error-proofing.
- Regulatory Compliance: Conduct technical investigations, non-conformance resolutions, and Corrective and Preventive Actions (CAPA) in line with regulatory standards.
- Technical Team Engagement: Collaborate with teams across Engineering, Manufacturing, Product Development, QA, Clinical & Regulatory Affairs.
- Problem Solving: Apply problem-solving techniques to identify issues, assess impacts, and implement resolution plans.
- Process Development Input: Provide insights on manufacturing process development, including process design, risk analysis, traceability, and design history.
- Equipment Selection and Evaluation: Lead equipment selection/design for prototype and full-scale production and upgrade process equipment as needed.
- Bachelor’s degree in Engineering (Mechanical, Pharmaceutical, Chemical, or Biomedical).
- Minimum of 3 years of experience in manufacturing engineering within the medical device industry.
- Familiarity with Quality System Regulations (QSR), Design Control, Process Validation, and Regulatory guidelines.
- Competency in Statistical Process Control tools (e.g., SPC, Minitab).
- Knowledge of chemistry, materials, and processing principles.
- Strong ability to prepare technical reports, summaries, and communicate effectively.
