Full-Time

Design Assurance Engineer

Posted on 5/14/2024

JUUL Labs

JUUL Labs

1,001-5,000 employees

Develops low-temperature nicotine vaporizers

Hardware

Mid

Remote in USA

Required Skills
Management
Requirements
  • Minimum of 3 years of design control/testing experience in consumer electronics and/or electro mechanical medical devices within an FDA QSR or ISO 13485 regulated environment
  • Exceptional cross-functional workplace collaboration
  • Possesses robust technical skills to facilitate critical, open and data-driven thinking
  • Demonstrates excellent attention to detail with respect to Quality and Regulations
  • Medical Device Experience is required
Responsibilities
  • Responsible for Risk Management, design control documentation, and assurance that Design and Manufacturing process changes are assessed for potential risks to customers or regulatory compliance
  • Assist the Design Assurance function to build a comprehensive Design Assurance system compliant to FDA requirements, by reviewing Design Control procedures and policies, and assisting in document writing
  • Provides assistance to JUUL Engineering to implement an improved and robust Design Control system
  • Reviews product change notices and change documentation to ensure thorough review of quality documents submitted for technical changes, design changes or manufacturing changes in order to ensure all regulatory requirements related to these changes are completely followed and conform to the Design Control regulations
  • Application of Reliability requirements, Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO 13485, IEC 62304, IEC 60601 and ISO 14971 Risk Management
  • Reviews and approves Verification and Validation methods including performance, biocompatibility, and manufacturing processes to ensure requirements are met
  • Assists in the determination of sample size, confidence levels, and associated statistics pertaining to Verification and Validation activities

JUUL Labs is committed to transforming the smoking industry with its advanced vaporizer technology, focused on delivering a low-temperature vapor to minimize combustion. This approach provides a satisfying alternative for adult smokers while incorporating stringent security measures to prevent underage usage. The company stands out in its commitment to public health and safety, making it an admirable workplace for those passionate about driving positive change in a challenging industry.

Company Stage

Series D

Total Funding

$16.2B

Headquarters

Washington, District of Columbia

Founded

2007

Growth & Insights
Headcount

6 month growth

-6%

1 year growth

-16%

2 year growth

-30%

Benefits

A place to grow your career. We’ll help you set big goals - and exceed them

People. Work with talented, committed and supportive teammates

Equity and performance bonuses. Every employee is a stakeholder in our success

Boundless snacks and drinks

Cell phone subsidy, commuter benefits and discounts on JUUL products

Excellent medical, dental and vision benefits

INACTIVE