Join Our Team as a Senior Quality Design Engineer!
Are you passionate about ensuring products meet the highest standards of quality and design excellence? Do you thrive in a dynamic environment where innovation is key? Career Management Group is partnered with a leading company that manufactures and distributes medical equipment serving the respiratory, sleep and cardiology patients, caregivers, physicians, and providers. We are looking for a talented Senior Quality Design Engineer to join our team and play a pivotal role in driving quality assurance initiatives from conception to implementation.
We're dedicated to pushing the boundaries of what's possible, creating products that make a real difference in people's lives. As a Senior Quality Design Engineer, you'll be at the forefront of this mission, working collaboratively with cross-functional teams to develop and maintain rigorous quality standards throughout the product lifecycle.
Qualifications:
7+ years of experience or equivalent experience in Medical Device Design control and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC 62366, IEC 60601.
Experience with new design (NPD), design transfer, design changes and sustaining of mechanical and software driven devices.
Experience with test method development and the validation of those test methods.
Experience with risk management file creation and updates.
Bachelor's degree in engineering, life sciences or related field.
Preferred Education:
Master's degree in engineering or life sciences discipline.
Preferred Experience:
Experience working with electronic circuit boards and cable assemblies.
DHF (Design History File) remediation when moving from one design control system to another.
EUMDR (European Medical Device Regulation).
Design for Six Sigma.
House of Quality.
Familiarity with electronic quality management systems.
Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people.
Duties and Essential Functions:
Each Employee consistently demonstrates the following essential functions:
If you're ready to take your career to the next level and make a meaningful contribution to our team, we'd love to hear from you! Apply now to join us as a Senior Quality Design Engineer and help shape the future of our products.