- 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.
