Full-Time
Senior Design Assurance Engineer
Posted on 4/10/2024
Smoking alternative
Compensation Overview
$104,000 - $182,000Annually
Senior
Remote in USA
- Minimum of 5 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
- Bachelor's Degree in Engineering (Electrical, Mechanical) or similar technical field required at a minimum
- Preferred Master's degree
- 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 mentorship 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
- Support Post Market in the analysis of Complaint data/ Adverse Events and develop corrective and preventive actions for quality incidents
- Lead and participate in internal and external audits to ensure compliance with quality standards and regulations
- Support the development and review of process validation test plans, protocols, and reports (MVPs)
JUUL Labs' mission is to transition the world's billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products.
Company Stage
Series D
Total Funding
$16.2B
Headquarters
Washington, District of Columbia
Founded
2007
6 month growth
↓ -6%1 year growth
↓ -15%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