Cadwell

Manufacturing Engineering Manager

Kennewick, WA

Sponsorship not specified$125k-$150kDetected 82 days ago

Process ImprovementHRFDA RegulatoryMedical DevicesProblem SolvingMentoringLean ManufacturingRegulatory Affairs

About the role

As the owner of how manufacturing at Cadwell is done this key role oversees a team of skilled Manufacturing engineers that ensure production is able to meet Cadwell's growing business demands.
Actively monitors the manufacturing industry for state of the art in these areas to ensure Cadwell's production environment is robust, efficient, and scalable

Oversees and leads the specification, development, and maintenance of production line test methods, processes, and fixtures; ensures that the approach to testing scales to meet Cadwell's growing business needs
Develop, maintain and track capital equipment budget for needed manufacturing investments
Oversees and leads the development and continuous improvement of Cadwell's equipment calibration program, defining the appropriate strategy for in-house versus outsourced calibration; ensures program efficiency, compliance, and scalability.
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
Oversees and leads the Manufacturing Engineering team through the NPI and design transfer processes; ensures that designs and their manufacturing processes are robust and repeatable
Provides mentorship and guidance to the Manufacturing Engineering team, assisting in their development and strategically growing and diversifying their skillset to best support Cadwell's success
Perform other duties as assigned

Comprehensive knowledge of Process Engineering and Optimization to improve efficiency, utilization, throughput and yield
Comprehensive knowledge of the device manufacturing environment and problem solving within its unique technical, regulatory, and operational challenges
Thorough knowledge and experience with change control processes and activities
Thorough knowledge of Continuous Improvement processes (i.e. Lean Manufacturing
Thorough knowledge of Automation and Technology Integration
experience with practical applications of technologies and smart manufacturing integration to increase quality and reduce rework.
Demonstrated ability to assess and clearly communicate risk with appropriate urgency, ensuring manufacturing programs stay on schedule
Thorough knowledge of Continuous Improvement processes (i.e. Lean Manufacturing - Six Sigma, Kaizen, 5S, etc.)
Bachelor's degree in engineering or equivalent experience

$125,000 - $150,000 USD
Bachelor's degree in engineering or equivalent experience
Typically has greater than seven (7) years of relevant professional or technical engineering management experience of increasing responsibility and difficulty of assignment

Ensure the team, process, 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
Ideally this experience is in a medical or similar safety-conscious, highly regulated industry

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.