Manufacturing Engineer

• Manage required builds for existing product development improvements/new product development in a pilot or in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, and troubleshooting assembly issues.
• Provide manufacturing capacity analysis of existing product lines.
• Lead the development of highly capable manufacturing processes for new existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
• Develop and coordinate the execution of process characterization and validation plans.
• Comply with applicable FDA and international regulatory laws/standards.
• Lead/support production line in non-conformance investigations and dispositions.
• Development of manufacturing documentation (MP, Traveler, BOM).
• Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
• Design and implement custom equipment/tools, fixtures and/or off the shelf equipment/tools, fixtures for highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
• Work with outside OEM Suppliers, internal/external machine shops and or other departments/groups.
• Application of statistical and analytical methods such as SPC, SQC, and DOE.
• Participation on project teams tasked with new process/product development and the successful transfer into manufacturing.
• Process background (development, capability, optimization, validation) within a regulated industry.
• Other duties as assigned or required.

• AutoCAD, Solid works, 3matic.
• Knowledge in materials associated with medical devices.
• knowledge in processes associated with medical manufacturing.
• Proficient in design and process FMECA/FMEA/Hazards Analysis/Risk Analysis, Process Validation, and variability reduction applications.
• Proficiency with program languages such as (g-code, CO++, VB etc.) but not required.

PHYSICAL DEMANDS –Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential physical demands:

• Physically able to sit, stand and walk for extended periods of time.
• Able to move about on foot; walk up and down stairs repeatedly as needed.
• Clarity of vision at 20 inches or more; able to view a computer monitor for extended periods of time.

All your information will be kept confidential according to EEO guidelines.