Job Summary:
The Manufacturing Engineer is responsible for supporting and improving manufacturing processes to ensure high-quality product output, optimal efficiency, and compliance with regulatory and quality standards. This role involves troubleshooting production issues, implementing process improvements, supporting new product introductions (NPI), and collaborating with cross-functional teams.

Key Responsibilities:

• Develop, implement, and optimize manufacturing processes for existing and new products.
• Provide daily technical support to production to resolve process and equipment issues.
• Lead root cause analysis and corrective/preventive actions (CAPA) for production-related problems.
• Participate in continuous improvement (CI) initiatives such as Lean Manufacturing, 5S, and Six Sigma projects.
• Collaborate with R&D and Quality teams during New Product Introduction (NPI) and design transfer activities.
• Support validation protocols (IQ/OQ/PQ), process documentation, and change control processes.
• Identify and implement cost reduction opportunities without compromising product quality.
• Maintain and update manufacturing work instructions, SOPs, and process documentation.
• Ensure manufacturing processes comply with ISO 13485, GMP, and safety requirements.

Requirements:

• Bachelor's Degree in Mechanical, Electrical, Mechatronics, Biomedical Engineering, or a related field.
• 2-5 years of experience in a manufacturing engineering or process engineering role, ideally within medical devices, life sciences, or precision instruments.
• Strong knowledge of manufacturing techniques, process validation, and lean methodologies.
• Familiarity with quality systems and regulatory standards (e.g., ISO 13485, GMP, FDA).
• Experience with CAD software, ERP systems (e.g., SAP), and data analysis tools.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication and teamwork abilities.

Preferred Qualifications:

• Experience in a cleanroom or regulated manufacturing environment.
• Six Sigma Green Belt or equivalent certification.
• Hands-on experience with automation or robotics in manufacturing is a plus.