What are the responsibilities and job description for the Manufacturing_Process Engineer position at Ihealth Labs Inc?
PRIMARY DUTIES AND RESPONSIBILITIES: (Additional duties may be assigned)
Process Development and Optimization
- Collaborate with cross-functional teams, including production and QA teams, to develop and improve manufacturing processes for In Vitro Diagnostic (IVD) products.
- Conduct feasibility studies and process reviews to optimize production processes, ensuring cost-effectiveness and scalability.
- Participate in continuous improvement initiatives to enhance production efficiency and effectiveness.
NPI Process Development
- Collaborate closely with the product design team to understand the requirements and constraints of new products.
- Ensure the manufacturing procedure and process meet the requirements correctly.
Quality Assurance and Compliance
- Implement and maintain rigorous quality control measures and compliance with relevant regulatory standards, such as FDA and ISO requirements.
- Participate in validation and verification activities to ensure the accuracy and reliability of diagnostic tests.
Data Analysis and Reporting
- Collect, analyze, and interpret production data and quality metrics to monitor process performance and identify opportunities for improvement.
- Prepare regular reports and presentations to communicate findings to management.
Production Planning and Inventory Management
- Assist in creating and maintaining production schedules to meet customer demands and production goals.
- Monitor inventory levels and coordinate with procurement to ensure materials are available for production.
Training and Collaboration
- Train manufacturing personnel on new processes, equipment, and best practices.
- Collaborate with cross-functional teams, including Production, Quality Assurance, Regulatory Affairs, Logistics, and R&D, to drive product development and improvement initiatives.
KNOWLEDGE/SKILLS/ABILITIES:
- A minimum of a bachelor's degree in engineering (industrial/mechanical) or a related field.
- Proven experience in process optimization, NPI, quality control, or related roles within a manufacturing environment.
- Familiarity with manufacturing processes, equipment, and automation technologies.
- Familiarity with IVD product manufacturing processes and regulatory requirements.
- Knowledge of quality management systems (e.g., ISO 13485) and FDA regulations (21 CFR Part 820) is a plus.
- Knowledge of Lean Six Sigma is preferred.
- Attention to detail and a commitment to quality.
- Excellent problem-solving and communication skills.
- Bilingual in English/Chinese is a plus.
Salary : $60,000 - $80,000
