Manufacturing Process Engineer

6 days ago

Pawtucket, Rhode Island, United States ZOLL Medical Full time

At ZOLL Medical, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software, and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Resuscitation division of ZOLL Medical develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

Job Summary

We're seeking a skilled Manufacturing Process Engineer to partner with our manufacturing, engineering, and quality teams in the design, implementation, and validation of new processes to manufacture high-quality medical devices and associated accessories. The ideal candidate will utilize a variety of tools to continuously improve existing manufacturing processes while acting as an innovator in the areas of Lean manufacturing processes.

Key Responsibilities
  • Optimize manufacturing processes to provide sustainable gains in gross margin and product performance through capital projects, statistical analysis, designed experiments, procedural changes, simulation, and modeling.
  • Provide on-going technical support to production lines for equipment, process, or design-related issues.
  • Monitor process and equipment performance; identify and implement process improvement activities to increase/optimize yield, efficiency, or throughput.
  • Maintain safety, product quality, and manufacturing effectiveness by examining equipment, processes, operations, product components, and assembly to determine time or quality revisions and suggest/implement improvements.
  • Work with suppliers and participate in multi-functional teams to resolve technical/quality issues and develop new products.
  • Participate in new product design and development reviews; suggest ways to enhance Design for Manufacturing (DFM); develop process Failure Mode and Effects Analysis (FMEA); lead transfer of products from design to production; support product scale-up activities.
  • Drive a Lean culture of continuous improvement; lead and participate in Kaizen events; promote 5S activity to standardize work; work with manufacturing managers to establish task time to maximize throughput, reduce cycle time, identify constraints, and balance work content; create and update value stream maps.
  • Specify, evaluate, select, and implement new equipment and fixtures; develop and execute installation, operation, and performance qualification protocols.
  • Design and implement validation protocols for process improvements and material changes, including comprehensive engineering reports providing analysis of results.
  • Develop efficient, effective systems for capturing critical process metrics for all manufacturing operations; implement automated data collection where possible.
Requirements
  • BS in Industrial Engineering required or other technical degree with equivalent experience required.
  • Minimum of 2-4 years' experience in a commercial manufacturing environment driving continuous improvement with demonstrated experience in use of rotary/converting equipment and automation of manufacturing processes required.
  • Medical device manufacturing experience with exposure to FDA requirements required.
  • Production of electromechanical assemblies required.
Preferred Qualifications
  • Experienced in designing and performing process validations.
  • Works well in dynamic, cross-functional team environments.
  • 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.

ZOLL Medical is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation, and an entrepreneurial spirit. We're committed to improving outcomes for underserved patients suffering from critical cardiopulmonary conditions and helping save more lives.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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