Process Development Engineer
The Process Development Engineer will design and optimize processes for the manufacturing of new medical devices. This role involves identifying and evaluating innovative processing options based on product attributes, considering both technical and economic feasibility.
The Engineer will implement cost-effective systems to improve the speed and quality of production, ensuring compliance with government regulations and industry standards.
U.S. Citizenship and a Bachelor’s Degree in Engineering are required.
Key Responsibilities :
- Collaborate with a team of engineers to design, develop, and implement new manufacturing processes for medical devices.
- Apply methodologies for efficient process development (design for manufacturing, test method validation, process validation, process capability, lean manufacturing, equipment selection, and specification development).
- Use a risk-based approach for process development, implementation, and validation.
- Maintain process documentation (PFMEA, production instructions, drawings) for new products.
- Work with R&D, Operations, and Production Engineering to ensure smooth transitions from R&D projects to manufacturing.
- Conduct cost-benefit analyses for in-house production or supplier selection.
- Define, identify, and procure new manufacturing equipment.
- Complete projects within set timelines while meeting performance expectations.
- Comply with the Quality Management System and regulatory requirements (FDA 21 CFR 820, ISO 13485, etc.).
Requirements :
- Bachelor’s Degree in Engineering.
- Experience in process validation, design for manufacturing, statistics, and lean manufacturing principles.
- Familiarity with process variation, process capability evaluation, and Design of Experiments (DOE).
- Experience in commissioning and qualifying new processes and equipment.
- Minimum 3 years of experience in Class II / III medical device manufacturing or a GMP-regulated environment.
- Knowledge of medical device standards such as ISO 13485 and FDA regulations.
- Strong problem-solving and analytical skills.
- Proficiency with Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project).
- Preferred : Experience with 3D modeling software (Creo, SolidWorks, etc.).
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