Senior Engineer, New Product Introduction (npi)/lifecycle Quality
Johnson & Johnson MedTech
Milpitas, California, United States
Base: $91,000.00 - $147,200.00; bonus/equity: not ...
On-site
Quality leadership on product teams
Risk management and human factors
Design control strategy and implementation
Johnson & Johnson MedTech is seeking a Senior Engineer for New Product Introduction and Lifecycle Quality in Milpitas, CA. The role focuses on ensuring quality and technical leadership for medical devices, emphasizing risk management and compliance within a collaborative team environment
Job Summary
The Senior Engineer, NPI and Lifecycle Quality provides quality and technical leadership to ensure new and existing medical devices meet their intended use.
Key responsibilities include ensuring Critical to Quality (CTQs) attributes are established, implemented, and met, and leading development teams in design control strategy and implementation.
The role involves collaborating with functional business partners to proactively address quality issues during new product development, design changes, and product verification/validation.
Matching Summary
Match Score: 85
Johnson & Johnson MedTech is seeking a Senior Engineer for New Product Introduction and Lifecycle Quality in Milpitas, CA. The role focuses on ensuring quality and technical leadership for medical devices, emphasizing risk management and compliance within a collaborative team environment.
Salary
Base: $91,000.00 - $147,200.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off
Skills & Requirements
Must-have
Quality leadership on product teams
Risk management and human factors
Design control strategy and implementation
Medical device regulations (QSR/ISO)
New product development quality
Nice-to-have
General quality management system concepts
Good documentation practice (GDP)
Corrective and preventive action (CAPA)
Key Requirements
Bachelors or equivalent university degree in Engineering or related technical field
4 years working experience in Design/Process Engineering/Science/Statistics in a regulated industry
Practical understanding of QSR/ISO medical device regulations