Manufacturing Engineer – Medical Device (No C2C)
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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
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).
- 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.
- 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.
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