| Manufacturing Engineer Medical Device at Raynham, Massachusetts, USA |
| Email: [email protected] |
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From: Manish Kumar, Scalable [email protected] Reply to: [email protected] Job Title: Manufacturing Engineer Medical Device Location: Raynham, MA (Onsite) Job Type: Contract Key Responsibilities: Operational Support: Provide hands-on support to the manufacturing organization to ensure smooth operations within the production area, working directly with associates on the floor to address any day-to-day issues. KPI-Driven Systems: Support the development of a KPI-driven production management system on-site, helping monitor performance and ensure continuous improvement. Automation & Systems Development: Develop, test, and implement effective automated and manual systems to optimize production processes. Process Optimization: Apply Lean, Six Sigma, Value Stream Mapping, and problem-solving tools to optimize manufacturing operations and improve product yields. Equipment Monitoring & Troubleshooting: Monitor performance of machines, tools, and equipment; correct any issues that cause non-conforming products, low yields, or quality problems. Cross-Functional Collaboration: Collaborate with teams across Production, Design Engineering, Quality Engineering, Supplier Engineering, and Project Management to meet project priorities, including Design Verification & Validation and product launches. New Product Transfers: Assist in the transfer of new products from design into manufacturing, including building prototype assemblies, training operators, and conducting process validation. Process Qualification & Validation: Develop, document, and qualify new manufacturing and test processes using statistical tools such as Design of Experiments (DOE), Process Capability (Cpk), and Gage R&R. BOM & Workflows: Specify and refine Bill of Materials (BOMs), workflows, and detailed work instructions for manufacturing processes. Risk Management: Create and revise manufacturing-related risk documents, including Process FMEAs, Manufacturing Line Specifications, and Equipment Specifications. Testing & Qualification: Generate validation and test protocols, monitor testing, issue qualification test reports, and approve components for use in products. Calibration & Maintenance Management: Oversee the calibration and preventive maintenance programs to ensure equipment functionality and reliability. Manufacturing Workflow: Organize and manage manufacturing workflows and resources to maximize production efficiency and quality. Cost Reduction & Quality Maximization: Identify and implement ways to reduce costs while ensuring high-quality standards in manufacturing. Training & Compliance: Train staff on new and existing manufacturing processes, ensuring adherence to safety and environmental regulations.Key Competencies: Medical Device & Regulations: Strong knowledge of medical device regulations, including FDA regulations (21 CFR, Part 820, Part 807) and ISO standards (e.g., ISO 13485). Manufacturing Process Knowledge: Expertise in implant medical device manufacturing processes, including casting, molding, precision machining, CNC milling, turning, surface finishing, and more. Continuous Improvement: Experience implementing Lean, Six Sigma, and KPI-driven systems to continuously improve production operations. Problem-Solving Tools: Strong proficiency in utilizing tools like Value Stream Mapping, Design of Experiments (DOE), Process Capability (Cpk), and Gage R&R for process optimization and problem-solving. Cleanroom Operations: Hands-on experience with daily cleanroom operations and ensuring compliance with cleanroom protocols. Project Management: Proven project management ability, with experience in managing new product transfers and equipment maintenance programs.Essential Skills & Experience: Manufacturing Engineer Experience: Minimum of 6 years of experience in a manufacturing environment, with specific experience in medical device manufacturing (preferably implants). Foundry & Implant Manufacturing Processes: Strong knowledge of foundry processes, casting, molding, and finishing in implant manufacturing, along with experience in CNC machining, surface finishing, laser marking, and sterilization. Regulatory Compliance: Extensive experience with FDA regulations and ISO standards related to medical device manufacturing. Tool Design & Fabrication: In-depth knowledge of tool design and fabrication methods used in manufacturing. Quality Control & Compliance: Experience with Quality Control, regulatory compliance, and quality systems for medical device manufacturing. Design for Manufacturing (DFM): Strong background in assisting with DFM processes to optimize product designs for manufacturability. Additive Manufacturing: Experience with 3D printing and additive manufacturing processes for medical devices.Desirable Skills: Communication: Strong communication skills to effectively collaborate with cross-functional teams and present complex technical information to non-technical stakeholders. Packaging & Cleanroom Experience: Previous experience in packaging, cleanroom environments, or machine shops (preferably in the medical device or aerospace industries). Validation Experience: Experience with validation processes (IQ/OQ/PQ) for manufacturing and test processes. Metal/Plastic Cutting: Understanding of different metal/plastic cutting manufacturing processes and their application in medical device production. Quality Systems Knowledge: Basic understanding of quality systems, including documentation and reporting standards. ------------ Manish Kumar Scalable Systems Technical Recruiter Mailto: [email protected] Keywords: rlang Massachusetts Manufacturing Engineer Medical Device [email protected] |
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| 07:31 AM 11-Mar-25 |