Cadwell

Manufacturing Engineer

Kennewick, WA

Sponsorship not specified$79k-$100kDetected 18 hours ago

Process ImprovementHRFDA RegulatoryMedical DevicesProblem SolvingLean ManufacturingRegulatory Affairs

About the role

As a hands-on owner of how manufacturing at Cadwell is done, this role ensures that production can reliably meet Cadwell's business demands while manufacturing high quality products.
If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at careers@cadwell.com Salary Range $79,000 - $100,000 USD

Specifies, develops, and maintains production line test methods, processes, and fixtures; ensures test approaches are repeatable, scalable, and support Cadwell's business needs
Troubleshoots production line issues to eliminate equipment and material as a source, and implements corrective and preventive actions on the production floor; escalates issues to engineering teams as necessary to
Supports the development and continuous improvement of Cadwell's equipment calibration program, executing in-house and outsourced calibration activities to ensure compliance and efficiency
Partners with other departments such as R&D, Supplier Quality, IT, Production, Regulatory Affairs, and Quality Assurance to ensure smooth design transfers and efficient day-to-day operation of the production environment
Supports the Manufacturing Engineering team through the NPI and design transfer processes; helps ensure that designs and their manufacturing processes are robust and repeatable
Perform other duties as assigned

Extensive use of a computer will be required
Travel may be required
must be able to obtain necessary travel documents
Work hours outside normal business hours may be required at times to meet business needs
Knowledge, Skills, and Abilities:
Working knowledge of the device manufacturing environment and problem solving within its unique technical, regulatory, and operational challenges
Working knowledge of Continuous Improvement processes (i.e. Lean Manufacturing - Six Sigma, Kaizen, 5S, etc.)
Familiarity with Automation and Technology Integration

Bachelor's degree in engineering or equivalent experience
Typically has greater than two (2) years of relevant professional or technical engineering experience
Typically has experience manufacturing regulated equipment.

Working knowledge of Process Engineering and Optimization to improve efficiency, utilization, throughput and yield
Knowledge of and experience with change control processes and activities
Working knowledge of Continuous Improvement processes (i.e. Lean Manufacturing
Six Sigma, Kaizen, 5S, etc.)
Ability to analyze data and situations, exercise sound judgment, plan and organize work, and communicate effectively across teams

Creates, maintains, and continuously improves the manufacturing systems (processes, equipment, training, etc.) used to manufacture Cadwell's medical devices, for both existing and new designs
Ensures processes and systems align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, 2017/745/EU Medical Device Regulation); supports internal and external audits from FDA and Notified Bodies

If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at careers@cadwell.com

t of every person to participate in all aspects of employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic info

This listing is sourced directly from Cadwell's careers page and normalized into a canonical job model.