NPI Systems Engineer – Global Launch & Design for Excellence

Quality Ai; Santa Clara (CA); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

401k matching

Healthcare benefits

Learning & Development

Global mobility opportunities

Wellness program

Employee perks

Job summary

Qualitest in Hercules, CA is seeking an NPI Systems Engineer to join the Global Supply Chain team. You will drive the seamless transition from development to launch, become a subject matter expert on subsystems, and collaborate with internal teams and suppliers to ensure high quality and manufacturability.

You will support R&D efforts and successful project launches, with travel to Singapore. Candidates with 3+ years in a product development environment,DfE experience, and CAD tool familiarity

Qualifications

• Minimum 3 years in a product development environment.
• Experience with Design for Excellence (DfE).
• Familiarity with DOORs, JAMA and SAP.
• Regulated industry experience preferred.
• Electromechanical background preferred.
• Knowledge of 3D CAD or electrical CAD tools (SolidWorks or Altium Designer).
• Degree in Mechanical, Electrical or Biomedical Engineering.

Responsibilities

• Oversee Design Transfer using Design for Excellence principles.
• Serve as SME on assigned subsystems and train as needed.
• Liaise between R&D, Manufacturing and Suppliers.
• Ensure easy assembly and high yield via design reviews and fixtures.
• Drive cost efficiencies through system design optimization.
• Apply LEAN principles in manufacturing and design.
• Support sustaining activities and future product lifecycle.
• Design and develop assembly/test jigs and fixtures.
• Maintain documentation per QMS for instrument industrialization.
• Develop workflows with the development team to ensure QMS compliance.

Job description

Qualitest in Hercules, CA is seeking an NPI Systems Engineer to join the Global Supply Chain team. You will drive the seamless transition from development to launch, become a subject matter expert on subsystems, and collaborate with internal teams and suppliers to ensure high quality and manufacturability.

You will support R&D efforts and successful project launches, with travel to Singapore. Candidates with 3+ years in a product development environment,DfE experience, and CAD tool familiarity