Job Description

Are you interested in building web applications that improve the lives of people with diabetes? As a Front-End Software Engineer, you will work on new features and functionality used by people with diabetes and their care teams, including clinics, hospitals, and healthcare organizations. This position is entirely remote and reports to Tapani Otala, Tidepool's VP of Engineering. 

Essential Duties and Responsibilities

• Collaborate with the product management team to understand, analyze, and refine product requirements of Tidepool Web and Tidepool Uploader
• Collaborate with the product design team to design user experience to meet the needs of a diverse customer base.
• Collaborate with other software engineers and QA to design, build, and test the new features and functionality, and debug and triage issues reported by users.

Qualifications

 Required:

• 2+ years of experience in developing web application software
• Experience with React framework
• Experience with designing and using REST APIs
• Experience with using unit test frameworks to automate testing

Preferred:

• Experience with deploying web apps to cloud service providers (AWS preferred)
• Experience with Storybook, familiarity with Figma
• Experience with React Testing Library, Jest, Mocha, Chai, or similar testing frameworks
• Experience with continuous integration and continuous delivery (CI/CD) tools
• Experience with visualizing medical or healthcare data

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Job Description

We are seeking an experienced and strategic leader to join our executive team as the VP of Regulatory and Quality. This role is crucial in ensuring our software as a medical device (SaMD) products meet the highest quality standards and comply with global regulatory requirements. The ideal candidate will have a proven track record in navigating complex regulatory landscapes, implementing robust quality management systems, and driving regulatory strategy and quality system compliance in an agile software development environment. While the regulatory team may grow over time, this is a hands-on role - you’ll be directly involved in creating Tidepool’s regulatory documents and managing Tidepool’s regulatory and quality processes. This role reports to Howard Look, CEO. 

Due to the changing needs of this role, Tidepool is amenable to structuring the role to benefit both the chosen candidate and Tidepool. This may include full-time exempt, fractional, or other. This role is remote.

Essential Duties and Responsibilities

• Develop and execute the overall regulatory and quality strategy for the company's SaMD products
• Lead the regulatory affairs and quality systems efforts, fostering a culture of quality and compliance
• Ensure compliance with FDA regulations, CE Marking requirements under EU MDR, and other international regulatory schemes(e.g., MDSAP)
• Oversee the implementation, maintenance, and use of Tidepool’s Quality Management System (QMS)
• Adapt quality and regulatory processes to support agile software development methodologies
• Manage relationships with regulatory authorities (e.g., FDA, MDSAP participants, EU Notified Bodies), and represent the company in regulatory discussions
• Guide product development teams on regulatory and quality system requirements
• Oversee FDA and international regulatory submissions and approvals for new products and product changes
• Oversee regulatory and quality system inspections/audits
• Develop and maintain standard operating procedures and training materials
• Stay current with evolving regulations and industry best practices, particularly in SaMD
• Collaborate with cross-functional teams to integrate quality and regulatory considerations into product development cycles
• Provide executive leadership with strategic advice on quality and regulatory matters
• Represent Tidepool in regulatory and industry working groups and public forums
• Inform clinical development plan to achieve successful regulatory authorization in target markets
• Coordinate regulatory strategy with selected partners for integrated diabetes management systems
• Author submissions and technical documentation to achieve SaMD authorizations in desired markets
• Develop systems to monitor product and facility submissions, certifications, renewals, and registrations
• Enhance design control processes to facilitate improvements in development, design transfer, and product release while maintaining compliance with applicable regulations/standards

Qualifications

• Bachelor's degree in a relevant field; advanced degree is a plus
• 5+ years of experience in global quality systems and regulatory affairs for medical devices
• Extensive knowledge of FDA and international regulations for medical devices, especially those specific to SaMD
• In-depth understanding of CE Marking requirements under EU MDR, and experience with MDSAP. Other international product registration experience is a plus.
• Proven experience implementing and maintaining Quality Management Systems for medical device companies
• Strong familiarity with agile software development methodologies and their application in a regulated environment
• Knowledge of AAMI TIR-45 and experience applying its principles to SaMD development. Experience with IEC 62304 is a plus.
• Experience with quality system and risk management processes and standards (e.g., ISO 13485 and ISO 14971)
• Strong leadership and team management skills
• Excellent communication skills, both written and verbal
• Ability to influence and collaborate effectively with cross-functional teams and executive leadership
• Strategic thinker with a track record of driving regulatory approvals and maintaining compliance
• Experience with diabetes management devices or similar chronic disease management technologies is a plus

Key Competencies

• Regulatory strategy development and execution
• Quality management system implementation and oversight
• Risk management and mitigation
• Agile methodology adaptation for regulated environments
• Cross-functional leadership and collaboration
• Continuous improvement mindset
• Adaptability to evolving regulatory landscapes
• Strategic planning and execution

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Job Description

Please note that due to the nature of this role and its requirements, candidates must be geographically located in the United States, and authorized to work. 

We are looking for an enthusiastic and highly motivated Data Science Intern to join our team. Data Science Interns at Tidepool partner closely with cross-functional team members from Software Engineering and Quality Assurance, and more. 

As a Data Science Intern at Tidepool, you will be embedded in a team working on novel biotechnology projects that will ship out to our users and clinical partners. You will work on research projects with real impact, taking ideas from conception through execution.

Qualifications

Essential Duties and Responsibilities:

• Work on the next generation of automatic insulin delivery (AID) algorithms.
• Develop well-crafted, rigorous, and clear data science analysis.
• Stay up to date with the literature on diabetes technologies.
• Present and discuss journal articles.
• Work directly with data scientists, QA engineers, and other developers.

Qualifications: 

• Experience with python required, experience with MATLAB would be a bonus.
• A strong foundation in one or more of the following would be a significant plus:
  • Differential equations and numerical integration methods.
  • Biology/physiology.
  • Control theory (PID, MPC, etc.).
  • Machine learning.
• Familiarity with version control. We use GitHub.
• Awareness of general coding best practices, documentation, and testing.
• You are curious and enjoy exploring new domains of knowledge.
• You are intrinsically motivated.
• You use your own judgment to move work forward and to seek guidance when needed.

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