Job Function: R&D Product Development
Job Sub Function: R&D Software/Systems Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Santa Clara, California, United States of America
Job Description:The Senior Design Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development.
Responsibilities:
- Launch and stabilize new product launches through concept, design, development, and steady-state processes.
- Drives the development of product requirements, verification strategies, and validation strategies.
- Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards
- Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Proactively engage partners to drive consensus and resolve issues in a timely fashion.
- Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
- Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
- Develop inspection and sampling plans, test methods, and transfer functions for products and components.
- Provide support and expertise in developing and executing a reliability strategy during new product development.
- Conducts projects and assignments with technical responsibility.
Basic QualificationsRequired: - Bachelor's Degree in Engineering from an accredited engineering school or related science field
- At least 5 years of quality experience
- New product development experience
- Experience in medical device industry or other highly regulated field
- Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity
- Previous work experience engaging in a team-based environment
- Ability to travel up to 25% Moderate domestic and international
Preferred: - Experience with medical electrical-mechanical systems
- Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment.
- ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
- Prior software quality engineering experience in a product development environment
Required Skills:Preferred Skills:Analytical Reasoning, Quality Compliance, Quality Control (QC), Quality Planning, Quality Tools, Quality Validation, Risk Analysis
The anticipated base pay range for this position is :$125,000.00 - $201,250.00
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