Senior Quality Engineer

Company Description

Founded in 1912, Illinois Tool Works Inc. (NYSE: ITW) is a diversified, Fortune 200 manufacturing company that delivers specialized expertise, innovative thinking, and value-added products to meet critical customer needs in a variety of industries. Ranked among Fortune’s Magazine’s most admired companies, the company focuses on solid growth, improving profitability and strong returns across its worldwide platforms and divisions. These divisions serve customers and markets around the globe, with a significant presence in developed as well as emerging markets. ITW’s revenues totaled $12.6 billion in 2020.

ITW Medical is comprised of two highly-respected medical product brands - Coeur & Filtertek – supplying medical devices anITW Medical is comprised of two strong medical product brands – Coeur and Filtertek - able to proactively meet the needs of customers in the marketplace.  Coeur is a leading provider of disposable medical products used in diagnostic imaging and other medical procedures.  The Filtertek product line is comprised of custom plastic insert molded filtration and flow control components for global OEM medical device customers. d components to global medical device brands.   Filtertek manufactures molded filtration and flow control components.  Coeur is a leading provider of disposable diagnostic imaging consumables. 

Job Description

GENERAL ACCOUNTABILITY:

This position will report to ITW Medical’s Global Quality Manager. The individual will be responsible for validations, scrap reduction and continuous improvement activities.  The individual will ensure that projects are implemented, internal/external quality issues are investigated, and root cause and corrective/preventive actions are identified and executed.  This position will be responsible for the Hebron, Ill and the Elk Grove Village, Ill locations, with primary activities in Hebron.

DUTIES AND RESPONSIBIITIES:

• New Product Development
  • Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA) creation
  • Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results
  • Manage Implementation and Documentation of IQ, OQ, PQ.
  • Ensure timely and conclusive validations.
• Process Control
  • Update existing inspection plans, test methods, and standard operating procedures
  • Conduct sample size determination, statistical analysis, training, and root cause analysis
  • Take lead in understanding/updating FMEA for new failure modes
  • Assist in process optimization
• Continuous Improvement
  • Drive and Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives
  • Perform routine engineering assignments of related tasks which are typically a focused portion of larger projects.
  • Lead cross-functional teams in continuous quality improvement projects, in particular, in scrap reduction and identification and elimination of non-value-added activities
  • Take lead in collection, review, analysis and trending of quality indicators for monthly and quarterly reviews
  • Manage and contribute to problem solving teams using standardized investigation processes/tools.

• Compliance
  • Participate in the Internal Audit process and assist in addressing observations
  • Participate in customer and regulatory body audits
• Other tasks and duties assigned

Qualifications

Position Skills and Experience Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. 

• Bachelor’s degree (required) in Biomedical Engineering field (desired).
• 5+ years related experience (required) in Medical Devices Industry (preferred).
• Ability to perform routine design and engineering tasks with some assistance.
• Solid understanding of engineering and mathematics principles.
• Ability to interpret product requirements from drawings, specifications, blueprints, etc. and to identify and drive corrections of inconsistencies or inaccuracies in same
• Able to command use of inspection and measuring instruments such as calipers, micrometers, and tensile strength testers
• Highly motivated, detail-oriented, eager to drive needed change in the organization
• Demonstrated use of strong analytical, problem solving, and teamwork skills in a leadership role
• Able to follow and to provide instructions in all formats: written, verbal,