Position: Sr. Project/Manufacturing Engineer
Work Location: Cleveland, Mississippi 38732
Duration: 12 Months Contract
About the Position:
- This position is a key role in the Injection Molding and Devices. Primary focus will be on implementing equipment refurbishment projects for a Contract Manufacturing Operation. Additional focus will also be on manufacturing equipment reliability and process support work within the Injection Molding and Devices Operations as well as supporting the launch of a product re-design and capacity expansion. Cross-functional project management will be involved in this role as well.
- The contract duration should be for 12 months with the option to extend to 24 months depending in final approved project scope, timeline, and funding.
- Specific project work for this contract opportunity will include -
o Upgrading obsolete hardware on existing automated assembly machines (new pressure decay testers, ultrasonic welders, silicone dispensing equipment).
o Support of procurement and qualification of new injection mold tooling.
o Validation/Qualification activities for new molds, machines, assembly equipment.
o Assist Project Manager with required project planning, project controls, and procurement work
Essential Duties and Responsibilities:
- Utilize engineering principles to design/modify precision assembly and/or manufacturing equipment.
- Provide controls expertise to support installation planning on equipment to be retrofitted or refurbished.
- Manage projects and coordinate validation to ensure minimal invasion to equipment and downtime of operation during retrofit/refurbishment.
- Procure equipment and vendor resources for application support at installation and validation.
- Prepare refurbishment schedules and manage tasks and coordinate validation tasks to minimize equipment downtime.
- Interface with plant and corporate groups as well as contractors and vendors.
- Must be able to interact with all levels of employees and functions such as quality, validation, manufacturing, purchasing, maintenance, etc.
- Manage installation, start-up, debug, and commission of existing/refurbished manufacturing processes.
- Support validation activities like hardware and software testing.
- Support product life cycle management including: product design changes, material changes, Supplier Notice of Change (SNC) assessments, specification changes, etc.
- Provide technical support/troubleshooting to all plant departments.
- Demonstrate proactive communication and problem solving.
- Responsible for adhering to FDA Design Control standards at all times.
- Responsible for adhering to and maintaining all department Standard Operating Procedures (SOPs), forms, log books.
- Perform process reviews and prepare technical reports detailing equipment operation and preventative maintenance.
- Develop User Requirement Specifications, Technical Specifications, and Design Specifications for new equipment or upgrades to existing equipment.
- Must be able to read and interpret blueprints, technical drawings, schematics, and computer-generated reports.
- Must be able to meet all cleanroom garbing & personnel protective equipment (PPE) requirements for areas of manufacturing where work needs to be done.
- Must be able to work flexible hours including some overtime work on nights and weekends as needed to support manufacturing/project activities.
- Bachelor degree in Engineering required. (Mechanical, Industrial, Electrical, or Computer degrees are preferred)
- 7+ years Engineering / Manufacturing experience required. FDA manufacturing experience is preferred.
- Programming/troubleshooting experience with automation controls, automated assembly, control systems, PLC's, HMI's, servo's, and vision inspection systems is required.
- Design software experience (like AutoCAD, Solid Works, etc.) is preferred.
- Six Sigma Black Belt Certification or industry standard equivalent is preferred.
- Plastic injection molding experience is a plus.
- Project Management skills and experience (including Microsoft Project software) are a plus.
- Lean Manufacturing skills and experience