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Manufacturing/Process Engineer

Location: Pawtucket, RI

Resuscitation

Overview

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

 

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

 

Job Summary

Responsible for partnering with the manufacturing, engineering and quality teams in the design, implementation and validation of new processes to manufacture high quality medical devices and associated accessories. Utilizes a variety of tools to continuously improve existing manufacturing while acting as an innovator in the areas of Lean manufacturing processes. Works with in-house personnel to develop test recommendations to ensure that product requirements meet customer expectations and are testable. Works to standardize manufacturing processes and put appropriate controls in place to monitor status. Interacts with product development engineers and is responsible for leading product transfer involving process capability and operator training.

 

Responsibilities

  • Optimizes manufacturing processes to provide sustainable gains in gross margin and product performance through capital projects, statistical analysis, designed experiments, procedural changes, simulation and modeling
  • Provides on-going technical support to production line for equipment, process, or design related issues
  • Monitors process and equipment performance; identifies and implements process improvement activities to increase/optimize yield, efficiency or throughput
  • Maintains safety, product quality, and manufacturing effectiveness by examining equipment, processes, operations, product components and assembly to determine time or quality revisions and suggests/implements improvements
  • Works with suppliers and participates in multi-functional teams to resolve technical/quality issues and develop new products
  • Participates in new product design and development reviews; suggests ways to enhance DFM; develops process FMEAs; leads transfer of products from design to production; supports product scale-up activities
  • Drives a Lean culture of continuous improvement; leads and participates in Kaizen events; promotes 5s activity to standardize work; works with manufacturing manager to establish task time to maximize throughput, reduce cycle time, identify constraints and balance work content; creates and updates value stream maps
  • Specifies, evaluates, selects, and implements new equipment and fixtures; develops and executes installation, operation, and performance qualification protocols
  • Designs and implements validation protocols for process improvements and material changes including comprehensive engineering reports providing analysis of results
  • Develops efficient, effective systems for capturing critical process metrics for all manufacturing operations; implements automated data collection where possible

 

 

  • Experienced in designing and performing process validations
  • Works well in dynamic, cross-functional team environment
  • Strong analytical skills and common sense with emphasis on a scientific method of problem solving
  • Able to model and simulate manufacturing flows
  • Able to accept and produce timely results on multiple concurrent projects of significant complexity
  • Able to write clear, concise and visual work instructions
  • Possess effective verbal and written communication and interpersonal skills to interact with associates at all levels of the organization
  • Knowledge of design controls, FDA and MDD requirements; able to work within a medical device quality management system
  • Strong project management skills sufficient to take a proposed solution from resource appropriation through project scheduling and execution as well as being able to work as part of a decision making team to bring about positive change
  • Has a fundamental drive for continuous process improvement

Qualifications

 

 

  • BS in industrial engineering or other technical degree with equivalent experience
  • Minimum of 7-10-years experience in a commercial manufacturing environment driving continuous improvement with demonstrated experience in use of rotary/converting equipment and automation of manufacturing processes. Specific experience in:
    • Medical device manufacturing experience with exposure to FDA requirements
    • Production of electromechanical assemblies

 

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.

 

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V.