JUUL's mission is to improve the lives of the world’s 1.3 billion adult smokers by driving innovation to eliminate cigarettes. Headquartered in San Francisco and backed by leading technology investors, JUUL Labs is disrupting one of the world’s largest and oldest industries.
We’re an exceptional team with backgrounds in technology, healthcare and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best engineers, scientists, designers, product and program managers, supply chain and operations experts, customer service and business professionals.
Reporting to the Director, Medical Devices, the Embedded Software V&V Engineer will work closely with the Director, Medical Devices to support engineering efforts required to successfully submit a connected device for regulatory approval.
- Work closely with electrical, firmware and software engineers to develop software architecture documentation.
- Collaborate with stakeholders to write firmware and software requirements and develop software requirements specifications.
- Lead software risk management, software verification and validation activities.
- Own and write medical device software life cycle development processes and procedures.
- Work closely with firmware QA and testing teams.
- Work closely with design assurance, quality systems and regulatory teams to achieve company goals.
- 5+ years of experience working on Class II and Class III medical devices.
- BS, MS in computer science.
- Demonstrated applied expertise in FDA requirements (21 CFR 820) and medical device regulations including ISO 13485, ISO 14971, IEC 60601, IEC 62366, and IEC 62304.
- Solid understanding of medical device cyber security and privacy guidelines and regulations (e.g, GDPR).
- Experience working on connected medical devices (mobile and cloud supported devices).
- Solid experience in preparing technical files for supporting regulatory submissions (including CE mark, US FDA).
- Strong working knowledge of support tools (e.g., Jira, Github)
- Good written and oral communication skills and experience writing SRS, software architecture documents, test protocols and reports.
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
- Location. Work in the heart of San Francisco, one of the world’s greatest cities
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