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Cook Group

Medical devices for minimally invasive care

Manufacturing Engineer 1

Process EngineeringConfirmed live in the last 24 hours
Full-timeCanton, IL, USAIn-person

About the Job

Requirements

  • A high school diploma with applicable experience is required.
  • A bachelor's degree in a related field is required; Engineering or Plastics is preferred.
  • At least 3 years of extrusion process development experience is required.
  • At least 5 years of work related to polymer processing is preferred.
  • Process validation experience (IQ, OQ, PQ) is preferred.
  • Equipment qualification experience (IQ, OQ, PQ) is preferred.
  • A fundamental understanding of engineering principles is required.
  • Knowledge of extrusion process development and extrusion tooling design is required.
  • Mechanical aptitude is preferred.
  • Understanding of ISO 13485:2016 is preferred.
  • Knowledge of CFR, FDA, OSHA, and environmental regulations is preferred.
  • Proficiency in Microsoft Office applications is required.
  • Troubleshooting and problem-solving skills are required.
  • Equipment and process troubleshooting experience is preferred.
  • Blueprint-reading experience is preferred.
  • Design of Experiments and Six Sigma experience are preferred.
  • The role may require exerting up to 20 pounds of force frequently, or a negligible amount of force constantly, to move objects.

Responsibilities

  • Provide process support for the extrusion department.
  • Work hands-on on the manufacturing floor.
  • Interact with production, product development, and quality teams.
  • Support product development activities, continuous improvement, complaint resolution, CAPA investigations, and other quality initiatives.
  • Provide technical support as the process expert for manufacturing issues in production departments; investigate and analyze problems to determine root causes and implement solutions to prevent recurrence.
  • Support and drive continuous improvement activities in the manufacturing department to improve operational performance, and lead the technical aspects of process validation projects.
  • Assist product development teams with design-for-manufacturability requirements for new products.
  • Support new capital equipment and tooling purchases with appropriate documentation and evaluation.
  • Manage multiple technically oriented projects by coordinating internal and external resources.
  • Collaborate on product complaint resolution.

Desired Qualifications

  • At least 5 years of work related to polymer processing.
  • Process validation experience (IQ, OQ, PQ).
  • Equipment qualification experience (IQ, OQ, PQ).
  • Mechanical aptitude.
  • Understanding of ISO 13485:2016.
  • Knowledge of CFR, FDA, OSHA, and environmental regulations.
  • Equipment and process troubleshooting experience.
  • Blueprint-reading experience.
  • Design of Experiments and Six Sigma experience.

About the Company

Cook Group

Medical devices for minimally invasive care

Cook Group manufactures medical devices focused on minimally invasive procedures. Its Cook Medical division develops and produces a broad portfolio—over 16,000 products—across cardiology, urology, gastroenterology, endoscopy, and vascular care. The company sells to hospitals and clinics worldwide, operating a B2B model in about 135 countries, with a European footprint centered in Ireland. As a family-owned business led by Carl Cook, it aims to support clinicians with reliable technologies and clinical support to expand alternatives to open surgery.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Paris, France
Founded
1963

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