6 years medical device product development experience
Experience with iso 13485 and design controls
This role partners with product development teams to deliver design quality for complex electromechanical medical devices and consumables
Job Summary
This role partners with product development teams to deliver design quality for complex electromechanical medical devices and consumables.
The successful candidate will translate user needs into design inputs while maintaining traceability through verification and validation deliverables.
You will support the Urology portfolio, including legacy products and recently launched technologies integrating capital equipment and fluid management.
Matching Summary
This role partners with product development teams to deliver design quality for complex electromechanical medical devices and consumables.
Salary
Base: $129,800 - $216,400 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Bachelor's degree in Science or Engineering
6 years medical device product development experience
Experience with ISO 13485 and design controls
Knowledge of IEC 60601 and IEC 62304 standards
Root cause investigation and risk management skills
Nice-to-have
Master's degree in relevant discipline
Certified Quality Engineer (CQE) certification
Six Sigma Green or Black Belt certification
Hands-on software code evaluation experience
Experience with new product launches
Key Requirements
Minimum 6 years experience in medical device design quality
Formal quality systems experience (ISO 13485)
Bachelor's degree in Science or Engineering required