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Manufacturing Engineer

1 month ago

Reston, Virginia, United States Intellectt Inc Full time
Job Title: Manufacturing Engineer - Medical Devices

Intellectt Inc is seeking a highly skilled Manufacturing Engineer to join our team in California. As a key member of our production team, you will be responsible for developing, optimizing, and maintaining manufacturing processes to ensure the highest standards of quality and compliance.

Key Responsibilities:
  • Design and implement manufacturing processes for new medical devices, ensuring scalability, efficiency, and regulatory compliance.
  • Lead the validation of manufacturing processes (IQ/OQ/PQ) and equipment to ensure consistent product quality. Ensure processes meet FDA and ISO 13485 standards.
  • Drive process improvements using Lean, Six Sigma, or other methodologies to enhance product quality, reduce waste, and increase operational efficiency.
  • Collaborate with R&D teams to ensure new products are designed for efficient manufacturability, cost-effectiveness, and compliance with regulatory standards.
  • Oversee the installation, qualification, and maintenance of production equipment. Develop and implement preventive maintenance schedules to minimize downtime.
  • Analyze and resolve technical issues related to manufacturing processes and equipment, ensuring minimal disruption to production.
  • Create and maintain detailed manufacturing process documentation, including work instructions, SOPs, and validation reports, to ensure compliance with quality management systems.
  • Ensure all manufacturing processes and equipment comply with FDA, ISO 13485, cGMP, and other applicable regulatory requirements.
  • Work closely with quality assurance, R&D, production, and supply chain teams to ensure seamless product launches and sustained production efficiency.
  • Perform root cause analysis for any product or process issues and implement corrective and preventive actions (CAPA).
Qualifications:
  • Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related field.
  • 5-8+ years of experience in manufacturing engineering within the medical device industry.
  • Strong knowledge of FDA, cGMP, ISO 13485, and other relevant medical device regulations.
  • Proficient in CAD software (e.g., SolidWorks, AutoCAD) for designing and analyzing manufacturing equipment and processes.
  • Experience with process validation (IQ/OQ/PQ) and equipment qualification.
  • Familiarity with Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
  • Strong project management skills, with the ability to manage multiple projects simultaneously.
  • Strong analytical, problem-solving, and troubleshooting skills.
  • Excellent communication and teamwork abilities.
  • Certifications: Six Sigma Green Belt or Black Belt, Lean Manufacturing certification, or equivalent certifications are a plus.
  • Ability to work in a fast-paced, highly regulated environment with strict attention to detail and timelines.
Preferred Qualifications:
  • Experience with automation and robotics in a manufacturing setting.
  • Experience in developing and scaling up manufacturing processes for Class II or Class III medical devices.
  • Knowledge of manufacturing software tools such as ERP, MES, or PLM systems.
  • Experience in working with cross-functional teams and leading process improvement projects.