Base: $91,000.00 - $147,200.00; bonus/equity: not ...
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Embedded software and hardware system verification
Medical device regulatory compliance
Design control compliance
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Johnson & Johnson MedTech is seeking a Sr. Design Quality Engineer for their Shockwave Medical team in Santa Clara, California. The role focuses on ensuring compliance and quality in medical device design and development, particularly for innovative solutions in treating cardiovascular diseases.
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Job Summary
Johnson & Johnson is pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.
The Sr. Design Quality Engineer works closely with internal departments to deliver safe and effective medical device designs compliant with regulatory standards.
Employees are eligible for comprehensive benefits including retirement plans, long-term incentives, and generous time off policies.
Matching Summary
Match Score: 75
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Johnson & Johnson MedTech is seeking a Sr. Design Quality Engineer for their Shockwave Medical team in Santa Clara, California. The role focuses on ensuring compliance and quality in medical device design and development, particularly for innovative solutions in treating cardiovascular diseases.
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Salary
Base: $91,000.00 - $147,200.00; Bonus/Equity: Not specified; Benefits: Retirement plan, 401(k), long-term incentive program, paid time off
Skills & Requirements
Must-have
Embedded Software and Hardware System Verification
Medical Device Regulatory Compliance
Design Control Compliance
Risk Management and FMEA
Quality Management System Implementation
Design Verification and Validation Testing
Cross-functional Team Leadership
Nice-to-have
Statistical Data Analysis
Complaint Investigations and MDR Reporting
Supplier Quality Audits
Process Improvement Initiatives
Proficiency in MS Office Suite
Ability to Manage Multiple Priorities
Coaching and Customer Centricity
Key Requirements
Bachelor’s or Master’s in software/electrical engineering
5+ years hands-on embedded software and hardware design experience
Experience in medical device system verification and validation testing
Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601, 21 CFR Part 820, EU MDR
Class III medical device experience
Experience with complaint investigations and MDRs preferred