Design Quality Engineer II at Nevro in Redwood City, California

Job Description:

Design Quality Engineer II

US-CA-Redwood City

Job ID: 2024-4474
Type: Regular Full-Time
# of Openings: 1
Category: Quality
HQ

Overview

The Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. This is a hands-on role where the Quality Engineer will apply diversified knowledge of engineering, verification and quality principles and practices for implantable medical devices, product software and accessories.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Follow procedures to guide development and ensure best engineering practice compliance with relevant regulatory requirements
• Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to development and validation across product development teams, including:
• Risk Management
• Cyber security risk assessment
• Systems, Software, Electrical and/or Mechanical design
• Design/Software Verification and Validation
• Human Factors
• Quality Investigations
• Design Transfer (Manufacturing review, Inspection methods development, Test Method Validations, Biocompatibility, Sterilization assessments, etc.)
• Software Design and Configuration management
• Support risk management processes and initiatives.
• Support internal and external regulatory audits, and other quality assurance functions.
• Define or identify potential compliance gaps and assess new regulations and standards, against existing or developing products.
• Work with departments to discuss quality system gaps, fixes, design solutions and risks.
• Perform other duties as required

Responsibilities

• Bachelor’s degree in science or engineering
• Equivalent work experience may be substituted for education requirement.
• 3+ years of Quality/Regulatory experience in a medical device or other regulated industry environment(s)

Qualifications

• Proficiency with medical device development life cycles specifically to design control and transfer related manufacturing processes and technologies
• Knowledge and working experience with Software Development LifeCycle processes, Good Manufacturing Practices, Good Documentation Practices, Design Control, and/or Corrective Action & Prevention methodology
  • Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans, preferred
• Understanding of EN ISO 14971, IEC 60601-1, IEC 62304, FDA Software Guidance and/or similar standards
  • Experience with ISO14708 or Active Implantable Medical Device Directives (90/385/EEC), preferred
• Developed written and oral communication skills and be able to work in a team environment
• Must have good problem solving skills and be able to work independently.
• Ability to effectively present information and respond to questions from groups of managers, clients, and the customers.
• Must be organized, detail-oriented and adaptable according to evolving situations at hand.

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.

PI240040194

Salary:

$86,422.00

Apply Now