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Senior Manufacturing Process Improvement Specialist
2 weeks ago
We are seeking a seasoned Manufacturing Engineer to support and enhance our manufacturing operations.
Key Responsibilities:- Design, develop, and optimize manufacturing processes for medical devices in compliance with regulatory requirements.
- Drive process validation activities including IQ/OQ/PQ and Test Method Validation ensuring efficiency, cost-effectiveness, and product quality.
- Collaborate with R&D, Quality, and Regulatory teams for smooth transfer of products from design to full-scale manufacturing.
- Analyze complex manufacturing challenges and implement improvements using Lean, Six Sigma, and structured problem-solving methodologies.
- Select, install, and qualify equipment (IQ/OQ/PQ) ensuring robust process capability.
- Provide technical leadership and mentorship to junior engineers and technicians.
- Support audits by preparing technical documentation and ensuring compliance with regulatory standards.
- Manage nonconformance investigations, root cause analysis, and corrective actions.
In this role, you will be responsible for collaborating with suppliers to ensure incoming materials meet specifications and quality standards.
Requirements:- Degree in Mechanical Engineering or related field.
- 5+ years of experience in manufacturing engineering.
- Proven track record of improving efficiency and reducing costs.
- Strong understanding of regulatory requirements and industry standards.
- Excellent communication and teamwork skills.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- Competitive compensation and benefits package.
About Us:
This is a fantastic opportunity to join a leading organization in the medical device industry. If you are a motivated and experienced Manufacturing Engineer looking for a new challenge, please submit your application.
