Job Title: Manufacturing Engineer (Medical Device Industry)
Location: United States (Location details specific to the role)
Duration: 12 months (Contract on W2)

Job Description:

We are seeking a skilled and detail-oriented Manufacturing Engineer to join our team within the medical device industry. In this role, you will be responsible for ensuring the efficient manufacturing of high-quality medical devices. You will collaborate with cross-functional teams to optimize manufacturing processes, improve product quality, and ensure compliance with industry standards and regulatory requirements. This is an excellent opportunity to contribute to the production of life-saving medical technologies in a regulated environment.

• Develop, implement, and optimize manufacturing processes for medical devices, ensuring efficiency, quality, and cost-effectiveness.
• Collaborate with design engineers to ensure that manufacturing processes can accommodate new product designs and meet regulatory requirements.
• Conduct root cause analysis for production issues and implement corrective actions to improve process efficiency and reduce product defects.
• Work closely with suppliers, vendors, and contractors to ensure the timely and cost-effective procurement of materials and components.
• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards throughout the manufacturing process.
• Lead the development and validation of manufacturing procedures, work instructions, and process flows for new and existing products.
• Support the development and execution of process validations (IQ, OQ, PQ) and ensure all production documentation meets quality standards.
• Monitor and improve key performance indicators (KPIs), such as yield, cycle time, and scrap rates, to drive continuous improvement initiatives.
• Perform equipment and tool calibration, maintenance, and troubleshooting to ensure production runs smoothly.
• Support design transfer activities from development to manufacturing, ensuring seamless integration into production.
• Assist in risk management and failure mode analysis (FMEA) to ensure product safety and reliability.
• Maintain technical documentation related to production processes, quality control, and regulatory compliance.

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
• 2-5 years of experience in manufacturing engineering, preferably within the medical device or biomedical industries.
• Knowledge of FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP) in the medical device industry.
• Experience with process design, process optimization, and continuous improvement methodologies (e.g., Lean Manufacturing, Six Sigma).
• Familiarity with CNC machining, injection molding, assembly processes, and other manufacturing techniques commonly used in medical device production.
• Experience with CAD software (e.g., SolidWorks, AutoCAD) for designing tooling, fixtures, and production layouts.
• Strong problem-solving skills and the ability to troubleshoot production issues effectively.
• Excellent communication skills for collaborating with cross-functional teams and documenting procedures.
• Ability to work in a fast-paced, regulated environment and manage multiple projects simultaneously.

• Experience with Class II or Class III medical devices.
• Six Sigma or Lean Manufacturing certification.
• Familiarity with Statistical Process Control (SPC) and other data-driven tools for monitoring and improving production processes.
• Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.