Job Opportunity || Manufacturing Engineer || Raynham, MA

Role Description:

• Provides support to the manufacturing organization to facilitate efficient operations within the production area. Spent time on shop floor environment and work with associates on the floor to address day to day issues• Support the development of a KPI-driven Production Management System on site.• Develop and test effective automated and manual systems• Optimize operations utilising Lean, Six Sigma, Value Stream Mapping and Problem-Solving Tools.• Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.• Collaborate with cross-functional teams (e.g. Production, Design Engineering, Quality Engineering, Supplier Engineering, Project Management) to meet project priorities including Design Verification & Validation and product launch. Examples include building prototype assemblies, training operators, identifying fixtures/tooling needed and conducting process validation.• Support continual improvement in production areas and leads key projects.• Assists in new product transfers from Design into Manufacturing Release.• Develop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing and test processes using statistical tools such as Design of Experiments (DOE), Process Capability (Cpk), and Gage R&R.• Specify and refine BOMs, workflows/travelers, and detailed work instructions.• Create and revise manufacturing-related risk documents including Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.• Generate validation and test protocols, monitor testing, issue qualification test reports and approve components for use in products.• Responsibility for management of the Calibration and Preventative Maintenance programs.• Organize and manage manufacturing workflows and resources• Find ways to reduce costs and maximize quality• Train staff in new and existing processes• Ensure that manufacturing procedures follow safety and environmental regulations

Experience (Years):

6-8

Essential Skills:

• Manufacturing Engineer required to support existing and future implant medical device manufacturing lines and systems with strong knowledge of foundry processes, including casting, molding, and finishing.• Orthopedic Implants Manufacturing Machinery experience such as Precision Machining Techniques, Foundry, CNC Milling and Turning, Live Tooling, Surface Finishing (Buffing Process, Electropolishing Process), Laser Marking process, Ultrasonic Cleaning, Sterilization and Packaging. • 3D Printing and Additive Manufacturing Experience• Daily cleanroom operations and driving a lean, KPI-driven and continuous improvement culture across the department. • Need to have good knowledge of tool design and fabrication methods. • This position will involve overseeing the maintenance and calibration of critical equipment-systems. • Other necessary manufacturing engineer skills include project management ability, commitment to quality, and familiarity with safety and environmental standards.• Hands on experience in Quality Control and Regulatory Compliance in Implant Manufacturing • Experience in FDA Regulations and ISO Standards: 21 CFR, Quality system regulation (Part 820), establishment registration (Part 807), and unique device identification (Part 830).• The candidate should have a strong background in manufacturing, mechanical, production, biomedical engineering or other related disciplines.• Design For Manufacturing (DFM) Assistance• Minimum six years of experience in a manufacturing environment, preferably in a foundry for Medical Product

Desirable Skills:

• Good communication skill,• Has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred)• Product / Manufacturing Transfer activities• Good experience validations (IQ/OQ/PQ)• Understanding of different types of metal/plastic cutting manufacturing processes• Basic understanding of Packaging, clean room, milling and or lathe machines• Understanding of basic Quality systems