דרושים United States, Walker

In this role you will coordinate business unit lean savings, goals and objectives through the use of statistical techniques by planning, scheduling, and executing process projects. You will communicate project status, and define and shape strategic planning efforts, including critical goal and objective development that identifies and improves critical processes necessary to achieve annual targets, including waste reduction to drive technical and operational improvement.

• Participate in the development and support of the West Business System (WBS), with the goal of sustaining operational standards on the site
• Create strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management
• Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools
• Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control
• Assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants
• Sets up and/or participates in continuous improvement events related to establishing a process or process improvement
• Ensure that workplace process improvements are visible, that savings are tracked, validated and posted
• Review control charts/data generated from facility processes to assure they are in a state of statistical control
• Manage capital and non-capital projects to improve capacity, quality, efficiency, utilization and safety at the lowest cost. Manage projects by maintaining project timelines and continuously evaluating actual project costs with budgeted costs so projects will be completed on budget and in a timely manner
• Collaborate with QA and Engineering to set up and conduct capability studies, designed experiments, sampling programs, process validations, etc. to evaluate the manufacturing capability of products/processes and provide input, analysis and actions related to the data generated from these studies
• Assists with facility/supplier audits and meetings, as required

• Bachelor's in Engineering or Statistics concentration; or recognized equivalent

• 10+ years of experience
• 5+ five years’ experience in a manufacturing/production environment.
• Must possess a Six Sigma Green Belt certification and have at least five (5) or more years of experience demonstrating and using Six Sigma/Lean tools and methodologies.

• Medical Device industry experience
• Six Sigma Black Belt certification
• Must have good interpersonal/leadership skills and be able to interface with all departments and team member levels.
• Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization.
• Excellent computer skills required including SAP, all MS Office applications, Mini-tab and other statistical software programs.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

• Minimal travel required.

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.

In this role, you will effectively plan and guide Engineering team, ensuring quality product and operational efficiencies are met.

• Mentor and may lead engineering team to achieve site and department goals in a fast-paced environment.
• Collaborate with cross-functional teams to develop and implement sustainable manufacturing processes and systems.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Perform and document engineering studies and evaluations.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Champion high-visibility projects. Develop project scope, timeline, savings, and cost estimations.
• Quote new automation lines, engineering services, etc. Develop design concepts for new automation.
• Write validation, user requirements, equipment specification, and other documents as needed.
• Establishes relationships with customer and automation suppliers in pursuit of win‐win results and ongoing business.
• Provide engineering assistance to assure plant, machinery, and processes are at an optimum level.
• Routinely evaluate and review employee performance.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the plant.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Perform other duties as assigned based on business needs.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

• Bachelor’s degree in Science or Engineering or commensurate experience

• 5-8 years of experience
• Strong automation background and experience with CAD and SAP systems a plus.

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.

• Must have effective problem solving and interpersonal skills.

Manufacturing environment: While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to walk; sit; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus. The performance of this position periodically requires exposure to typical manufacturing areas were under certain conditions that require the use of personal protective equipment such as Safety Glasses with Side Shields and hearing protection. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles. Industrial lighting provided. The noise level in the production manufacturing work environment is usually moderate to loud; hearing protection is required.

Effectively plan and guide Engineering department, ensuring quality product at a minimum cost.

• Leads the site engineering department for the execution of new projects, maintain current production lines in optimal performance, Expansion plans and facility modifications.
• Provide engineering assistance to assure plant, machinery and processes are at an optimum level.
• Provide assistance and make recommendations to Division Engineering on a timely basis.
• Administrate maintenance management software.
• Ensure plant is in compliance with OSHA and local, state and federal environmental regulations.
• Routinely evaluate and review employee performance.
• Write validation, user requirements, equipment specification and other documents as needed.
• Promote and support a Lean Manufacturing environment within the facility.
• Improve processes and procedures to manufacture a quality product at a minimum cost.
• Quotes new molds, engineering services, automation, etc. for new and existing customers. Develops suppliers and maintain audit. Develops design concepts for new molds.
• Provide leadership to engineers. Provide and schedule tools and supplies for departments. Assume responsibility for various engineering projects as assigned.
• Facilitate meetings with the customer both on and off site to determine the needs, requirements, and customer specifications. Establishes relationships with customer and tooling suppliers in pursuit of win‐win results and ongoing business.
• Provide and schedule training for the department. Purchases tooling related equipment in accordance with the company policy.
• Responsible for project cost accounting and delivering projects on schedule and at budget.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain machine and plant equipment drawings.
• Manage and oversee the functioning of the site engineering and maintenance groups.
• Develop initial project scope, timeline, savings and cost estimations.
• Write Project and Capital Request and project justification documents.
• Develop equipment requirements.
• Research new technologies and methodologies to use in the plant.
• Present justification to management and/or customer to attain approvals.
• Lead project teams and team meetings as required.

• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance .

• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly and safe workstation and environment at all times.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibits regular, reliable, punctual and predictable attendance. Performs other duties as assigned based on business needs.

• Education or Equivalent Experience:​Bachelor's in​Engineering or Science field is preferred.

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate odors, fumes, particulate and loud noises generated from plastics manufacturing and molding processes.
• Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• Must be able to work in a controlled clean room and/or white room environment requiring special gowning. Will be required to follow hygiene and gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• Ability to stand and sit for extended periods of time.
• Requires occasional bending at the waist, twisting (at the torso and neck), crouching, climbing, kneeling, balancing, reaching (including overhead), pushing, pulling, grasping, holding and manual dexterity.
• Must transport oneself to and from other areas of the facility when necessary.
• Ability to understand verbal or written directions, which may include reading English and understanding symbols and warnings.
• Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Must be able to lift a minimum of 25lbs.

The Controls Technician is responsible for maintaining, troubleshooting, and continuous improvement on electrical and automated control systems within our medical device manufacturing facility. This role ensures that all production equipment functions efficiently and safely, complying with industry standards and regulations.

• Diagnose and resolve issues with automated assembly equipment, including PLCs, HMIs, robots, vision systems, sensors, and other control devices. Assist the assembly maintenance team with resolving electrical and controls related issues and helping to resolve escalated equipment issues.
• Perform regular maintenance on electrical and control systems to ensure continuous production operations.
• Collaborate with engineering and production teams to identify opportunities for process and system improvements. Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Assist with the installation and commissioning of new control systems and equipment upgrades.
• Maintain accurate records of system layouts, wiring diagrams, and maintenance logs.
• Ensure all control systems comply with relevant medical device manufacturing regulations and quality standards, such as ISO 13485 and FDA guidelines.
• Adhere to all safety and environmental policies and standards in the execution of work duties.
• Other duties as assigned.

• Strong analytical and troubleshooting skills.

• Excellent verbal and written communication skills.

• Ability to work collaboratively in a fast-paced, cross-functional team environment.

• Associate degree in Electrical Engineering, Industrial Automation, or a related field.

• 3+ years of experience in a controls technician role within a manufacturing environment, preferably in the medical device sector.
• Proficiency with PLC programming (e.g., Allen-Bradley, Siemens), HMI development, Vision programming (e.g., Cognex, Keyence), Robots (e.g., Fanuc, ABB), and SCADA systems.
• Familiarity with GMP, ISO 13485, and FDA regulations in medical device manufacturing.

• Experience in automation equipment used in medical device industry or other regulated industry.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and ISO 9002.

• Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity and distinguish color differences for product and safety issues.
• Medical Device manufacturing requires strict adherence to standards. Working environment is a clean room manufacturing facility, which houses plastic injection molding machines. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.

The Controls Technician is responsible for maintaining, troubleshooting, and continuous improvement on electrical and automated control systems within our medical device manufacturing facility. This role ensures that all production equipment functions efficiently and safely, complying with industry standards and regulations.

• Diagnose and resolve issues with automated assembly equipment, including PLCs, HMIs, robots, vision systems, sensors, and other control devices. Assist the assembly maintenance team with resolving electrical and controls related issues and helping to resolve escalated equipment issues.
• Perform regular maintenance on electrical and control systems to ensure continuous production operations.
• Collaborate with engineering and production teams to identify opportunities for process and system improvements. Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Assist with the installation and commissioning of new control systems and equipment upgrades.
• Maintain accurate records of system layouts, wiring diagrams, and maintenance logs.
• Ensure all control systems comply with relevant medical device manufacturing regulations and quality standards, such as ISO 13485 and FDA guidelines.
• Adhere to all safety and environmental policies and standards in the execution of work duties.
• Other duties as assigned.

• Associate degree in Electrical Engineering, Industrial Automation, or a related field.

• 3+ years of experience in a controls technician role within a manufacturing environment, preferably in the medical device sector.
• Proficiency with PLC programming (e.g., Allen-Bradley, Siemens), HMI development, Vision programming (e.g., Cognex, Keyence), Robots (e.g., Fanuc, ABB), and SCADA systems.

• Familiarity with GMP, ISO 13485, and FDA regulations in medical device manufacturing.
• Strong analytical and troubleshooting skills.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a fast-paced, cross-functional team environment.

• Must be able to perform job duties as required with limited physical demands.

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for technicians.
• Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Education: Associate degreein Engineering or Science field

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.
• Some validation experience – computer systems, equipment and process required and

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy and quality policy at all times.

• Manufacturing\Lean Six Sigma Certification-IASSC or Agile preferred
• Program and Project Management\Certified Project Management Professional (PMP)-PMI Knowledge of Agile and Waterfall methodologies preferred

In this role, you will supervise technicians in a manufacturing environment and be responsible for maintaining equipment of automated assembly lines. You will be the first point of contact during the escalation of any technical issues regarding automation during your teams’ shifts and will be responsible for teaching and encouraging growth in all night shift technicians.

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for night shift technicians under your supervision. Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Associates in Engineering or Science field is preferred.

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy and quality policy at all times.

• Must be able to perform job duties as required with limited physical demands.