Senior Design Quality Engineer, NPD

Job Function

R&D Product Development

R&D Software/Systems Engineering

Scientific/Technology

Santa Clara, California, United States of America

The Senior Design Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development.

• 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.

• 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
• GD&T knowlegde
• 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

• Advanced Degree
• 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

Analytical Reasoning, Quality Compliance, Quality Control (QC), Quality Planning, Quality Tools, Quality Validation, Risk Analysis

$ - $

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
  10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.