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Sr. Manufacturing Engineer- FDA Manufacturing

Job Description

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.

Qualifications:

  • 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

Job Requirements

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. Qualifications: 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

Job Snapshot

Location US-MS-Cleveland
Employment Type Contractor
Pay Type Year
Pay Rate N/A
Store Type Energy, Oil & Gas, Engineering & Aerospace, Health Care
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Company Overview

ACS Solutions

ACS Group provides services to Fortune 1000 companies across various industry verticals. With a proven track record of managing project demands while improving the efficiency, productivity and profitability of new and existing projects through process improvement, ACS Group is consistently recognized for identifying and implementing strategic solutions that create and preserve long-term business value. Learn More

Contact Information

US-MS-Cleveland
American CyberSystems, Inc.
(303)481-5170
Snapshot
ACS Solutions
Company:
US-MS-Cleveland
Location:
Contractor
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Energy, Oil & Gas, Engineering & Aerospace, Health Care
Store Type:

Job Description

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.

Qualifications:

  • 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

Job Requirements

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. Qualifications: 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
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