JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, 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.
ROLE AND RESPONSIBILITIES:
The Director of Medical Device will be leading and growing a talented cross-functional team of medical device engineers to explore the transition of JUUL products from a consumer product into a medical device and help support US and international regulatory filings. The ideal candidate must have a strong track record for managing, building, growing, and mentoring a team of Product Development Engineers in a Medical Device environment. We are looking for a results-oriented candidate that leads through building relationships, is motivated by collective success, and is passionate about working for a high performance, high intensity, high growth company.
- Developing and growing a medical device engineering team
- Drive the broader team into a new market opportunity area using the foundations of our existing market leading products and technology
- Finding and hiring incredible people who you’ll be excited to work with.
- Helping our engineers assess, document, plan and navigate the FDA approval process - by management, mentorship, and by contributing yourself.
- Manage, direct and support the Medical Device team. Hire, train, develop, teach, coach, mentor, motivate, discipline, and reward staff members.
- Own and successfully deliver CMC related engineering deliverables for all FDA filings
- Demonstrate efficient and effective maintenance of proper design controls, risk management and design history files
- Ensures engineers follow appropriate documentation guidelines and hold design reviews in accordance with product development procedures.
- Work and manage outside engineering consulting houses to get
- Leads team in developing, validating, and documenting product, test and process requirements.
- Demonstrate expertise level knowledge of medical device product design and development.
- Generate test protocols, reports and supporting documentation for formal design verification.
- Meet regularly with direct reports to review performance, identify any issues and set expectations and goals.
- Determines resource needs, develops plans, tracks progress to those plans, resolves conflicts and delivers scheduled milestones to projects.
- Reviews and evaluates product quality, cost effectiveness and manufacturing performance to standards and takes action as necessary to correct variances.
- Mentors less experienced staff on technical issues and handling projects and responsibilities; considered a strong leader and role model for the engineering department.
- Work with senior management in the prioritization and assessment of future projects and company and department goals.
- Demonstrate ability to work closely with cross functional teams such as Design Assurance, Quality Systems, Regulatory, Pre-clinical and Clinical
- Strong project management skills required. Capable of overseeing cross-functional teams in all project activities necessary for the successful submission and launch of new products.
- Active, high-energy communicator who drives a company vision/mission to align teams, critical resources, management, and stakeholders.
- Demonstrated track record of developing and launching successful, innovative electro-mechanical products; has a thorough understanding of a variety of manufacturing processes and how they affect design decisions.
- A bachelor's degree in mechanical or electrical engineering or related degree is required with a minimum 12 years of relevant engineering experience. A minimum of 5 years of functional management with direct reports. Master’s degree preferred.
- Experience leading CMC teams focused on product development, device development & engineering
- Proficient in US FDA , EU and Japanese regulatory requirements for medical devices and combination products.
- Strong working knowledge of engineering principles (mechanical, electrical and material) and strong analytical and problem solving skills.
- Experience with design and manufacturing of medicinal inhalers, drug- device combination products is a plus.
- Experience with design and manufacturing of high volume disposable and/or durable electro-mechanical medical devices and in mechanical/electrical/materials testing and test method development is required.
- Knowledge of general manufacturing processes including injection molding, SMT, machining, and various plastic part joining technologies.
- Knowledgeable in Design for Six Sigma and solid experience in statistical techniques, Lean and Six Sigma. Six Sigma certification highly preferred.
- Demonstrated ability to clearly and effectively communicate (verbal & written).
- Strong analytical, problem solving and technical writing skills.
- Strong leadership and interpersonal skills.
- Ability to travel domestically and internationally.
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