Senior Quality Engineer; NPD

Position

Sr. Quality Engineer, New Product Development

Location:

Santa Clara, California, United States of America

• Launch and stabilize new product launches through concept, design, development, and steady‑state processes.
• Drive the development of product requirements, verification strategies, and validation strategies.
• Ensure new product development compliance with GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), and any other applicable standards, driving prevention and detection of defects at the earliest phase of product design, continuous improvement, and customer satisfaction.
• Proactively engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support, expertise, and analytical problem‑solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering, and validation/qualification documents for conformance to 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.
• Conduct 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 with GD&T knowledge.
• Experience in the medical device industry or another 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.

$ – $

• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 hours for employees in Colorado, 56 hours for employees in Washington).
• 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.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time‑Off – 80 hours per calendar year.
• Eligibility to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), long‑term incentive program, and other benefit programs.