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 Senior Systems Engineer will be a core technical member of the medical device team and will help define and lead engineering efforts required to successfully submit a connected device for regulatory approval. Additional responsibilities include working on a next generation medical device.
- Help establish a medical device development laboratory with a focus on new product development, design verification and validation. Source, install and validate necessary equipment and test methods.
- Collaborate with cross-functional teams to create detailed subsystem and system level requirements specifications.
- Create engineering product requirements, technical specifications and maintain traceability to design outputs (e.g., design trace matrix).
- Prepare technical documentation, including test methods, protocols, and reports, to support design control activities and regulatory submissions
- Lead system fmea and risk analysis activities
- Be curious and lead product characterization activities
- Train and coach others and provide guidance on design controls, risk management, and other regulatory requirements.
- 5+ years of experience with medical device product design & development.
- BS EE/ME or related degree. Masters/PhD a plus.
- Solid engineering fundamentals in electrical, mechanical, software, systems, and/or other fields.
- Prior experience working on complex electromechanical medical devices, combination devices and/or connected medical inhaler products a plus.
- Experience working with third party suppliers of equipment and measurement systems.
- Experience in working with both domestic and international manufacturing partners.
- 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.
- Good documentation practices and strong communication skills
Expertise in one or more of the following areas
- Solid hands-on experience in analog and digital electronic circuit design, prototyping, board bring-up and troubleshooting
- Solid hands on experience design, installation and qualification of electrical and mechanical systems, test fixtures and rigs.
- Experience prototyping systems with various sensors for biomedical applications.
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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