Manufacturing Engineer – Medical Device (No C2C)

Hello ,

One of my clients is looking Role: Manufacturing Engineer – Medical Devices, if you’re interested or your skills matches, please share with me your updated resume to [email protected]

Job Title: Manufacturing Engineer – Medical Devices

Location: California

Duration: 12 Months

Note: No C2C

Job Overview

As a Manufacturing Engineer specializing in medical devices, you will play a critical role in developing, optimizing, and maintaining manufacturing processes to ensure that products meet the highest standards of quality and compliance. You will collaborate with cross-functional teams to design, validate, and improve processes for the manufacturing of medical devices, ensuring they adhere to FDA, ISO 13485, and other relevant regulatory requirements.

Key Responsibilities

• Process Development: Design and implement manufacturing processes for new medical devices, ensuring scalability, efficiency, and regulatory compliance.
• Process Validation: Lead the validation of manufacturing processes (IQ/OQ/PQ) and equipment to ensure consistent product quality. Ensure processes meet FDA and ISO 13485 standards.
• Continuous Improvement: Drive process improvements using Lean, Six Sigma, or other methodologies to enhance product quality, reduce waste, and increase operational efficiency.
• Design for Manufacturability (DFM): Collaborate with R&D teams to ensure new products are designed for efficient manufacturability, cost-effectiveness, and compliance with regulatory standards.
• Equipment Installation and Maintenance: Oversee the installation, qualification, and maintenance of production equipment. Develop and implement preventive maintenance schedules to minimize downtime.
• Troubleshooting and Problem Solving: Analyze and resolve technical issues related to manufacturing processes and equipment, ensuring minimal disruption to production.
• Documentation: Create and maintain detailed manufacturing process documentation, including work instructions, SOPs, and validation reports, to ensure compliance with quality management systems.
• Regulatory Compliance: Ensure all manufacturing processes and equipment comply with FDA, ISO 13485, cGMP, and other applicable regulatory requirements.
• Cross-functional Collaboration: Work closely with quality assurance, R&D, production, and supply chain teams to ensure seamless product launches and sustained production efficiency.
• Root Cause Analysis: Perform root cause analysis for any product or process issues and implement corrective and preventive actions (CAPA).
  
  

Qualifications

• Education: Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related field.
• Experience: 5-8+ years of experience in manufacturing engineering within the medical device industry.
• Regulatory Knowledge: Strong knowledge of FDA, cGMP, ISO 13485, and other relevant medical device regulations.
• Skills:
• 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.
• Other Requirements: 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.