Manufacturing and Process Development Engineer II
4 weeks ago
Key Responsibilities:
- Develop and implement manufacturing processes and technologies to improve product quality, operational efficiency, and cost-effectiveness.
- Collaborate with cross-functional teams to ensure seamless integration of new products and processes into manufacturing.
- Design, fabricate, or source fixtures and tooling using CAD software.
- Conduct process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Train manufacturing personnel in new processes and technologies.
- Lead a culture of Continuous Improvement by applying lean manufacturing principles to streamline operations, reduce waste, and enhance productivity.
Requirements:
- Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related field.
- 3-6 years of hands-on professional experience in manufacturing and process development within the medical device industry (ISO 13485 or FDA regulated).
- Familiarity with FDA regulations and ISO standards related to medical devices.
- Technical skills in design and/or CAD experience, statistical analysis, and lean six sigma methodologies.
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