Job Title: Manufacturing Engineer (Medical Device Industry)
Duration: 12+ Months (W2)

Job Description:
We are seeking a skilled Manufacturing Engineer to join our team in the medical device industry. This role is responsible for optimizing manufacturing processes, ensuring high-quality product standards, and supporting the design, development, and validation of production operations. The ideal candidate has experience in process improvement, medical device regulations, and hands-on experience with equipment validation.

Key Responsibilities:
Process Development & Optimization: Design, develop, and implement efficient manufacturing processes to improve product quality and productivity, reduce costs, and support continuous improvement.
Validation & Compliance: Conduct validation activities (IQ/OQ/PQ) for new and existing equipment and processes, ensuring compliance with FDA and ISO 13485 regulations.
Manufacturing Support: Provide ongoing support for manufacturing operations, troubleshooting issues, and implementing corrective actions to maintain production quality and efficiency.
Design for Manufacturability (DFM): Collaborate with design and product development teams to ensure that new products are optimized for manufacturing.
Documentation & Reporting: Create and maintain detailed documentation, including process flow diagrams, work instructions, validation protocols, and engineering change orders.
Lean Manufacturing: Apply Lean and Six Sigma principles to improve process efficiency, reduce waste, and enhance production flow.
Cross-Functional Collaboration: Work closely with quality, regulatory, and R&D teams to ensure products meet all regulatory, quality, and safety standards.
Supplier Interaction: Collaborate with suppliers to ensure quality materials and components, address quality issues, and drive improvements.

Qualifications:
Education: Bachelor's degree in Mechanical, Industrial, or Manufacturing Engineering or a related field.
Experience: 3+ years of experience as a manufacturing engineer, preferably in the medical device industry.
Regulatory Knowledge: Familiarity with medical device regulations, including FDA (21 CFR Part 820) and ISO 13485.
Validation Expertise: Hands-on experience with process and equipment validation (IQ/OQ/PQ) is essential.
Technical Skills: Proficiency in CAD software (e.g., SolidWorks, AutoCAD), as well as statistical analysis and quality management tools (e.g., Minitab).
Lean & Six Sigma: Strong background in Lean Manufacturing principles and Six Sigma methodologies.
Problem-Solving Skills: Strong analytical and troubleshooting skills to quickly resolve production issues and implement effective solutions.
Communication Skills: Excellent written and verbal communication skills with the ability to collaborate with cross-functional teams.