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Senior Design Assurance Engineer, Risk Management

Company: Juul Labs
Location: San Francisco
Posted on: August 7, 2022

Job Description:

THE COMPANY:

Juul Labs' mission is to impact the lives of the world's one billion adult smokers by eliminating combustible cigarettes. We have the opportunity to address one of the world's most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.

We are a diverse team that is united by this common purpose and we are hiring the world's best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.

ROLE AND RESPONSIBILITIES:

We are seeking a Senior Design Assurance Engineer, e-liquids to independently support both new product development and design changes. The ideal individual will ensure product quality, reliability, speed to market, reduction of risk to users, and regulatory compliance.

Additional Responsibilities:

  • 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
  • Responsible for Risk Management, 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 and 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, ISO13485, ICH Q9, IEC 60601 and ISO 14971 Risk Management

    PERSONAL AND PROFESSIONAL QUALIFICATIONS:
    • Minimum of 4 years of design control/testing experience in consumer electronics and/or electro mechanical medical devices within an FDA QSR or ISO 13485 regulated environment
    • Star candidate possesses the following three traits:
      • Exceptional workplace collaboration and customer service
      • Possesses robust technical skills to facilitate critical, open and data driven thinking o Demonstrates an excellent attention to detail and respect for Quality and Regulations
      • Medical Device Experience is required
      • Experienced or educated in Electrical Engineering, Firmware Engineering, or Software Engineering

        EDUCATION:
        • Bachelor's Degree in Engineering or similar technical field required at a minimum. Master's Degree preferred.

          JUUL LABS PERKS & 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

            Juul Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. Juul Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Juul Labs in the US.

Keywords: Juul Labs, San Francisco , Senior Design Assurance Engineer, Risk Management, Executive , San Francisco, California

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