• Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485 • Lead and responsible for human factor engineering activities as per the regulatory guidelines • Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget • Execute Risk Management Programs and Analyses in accordance with Kaléo's Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019 • Provide leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities • Help build Kaleo’s intellectual property portfolio • Manage project and program budgets and timelines effectively • Author and review regulatory submissions (as needed) • Responsible for reporting progress, risks, and opportunities to senior management on an ongoing basis to ensure good progress on all development portfolio programs

• Lead, mentor, and grow a team of 5–10 engineers while remaining hands-on with architecture, system design, and technical direction • Contribute directly to the codebase as an individual contributor, helping accelerate development velocity and establish high engineering standards • Lead engineering strategy and execution for a brand-new, high-priority initiative • Partner cross-functionally with Product, Design, Data, Marketing and Operations to deliver an exceptional parent experience • Collaborate with senior leadership to align on strategy, priorities, metrics, and long-term roadmap planning • Foster a culture of technical excellence, ownership, experimentation, and continuous growth through mentorship and feedback • Lead adoption of AI-development principles and agentic engineering workflows across the organization • Help define and implement modern engineering practices that leverage AI to improve developer speed and productivity, and product quality

Role Description There is no one-size-fits-all career path at Thoughtworks: however you want to develop your career is entirely up to you. But we also balance autonomy with the strength of our cultivation culture. This means your career is supported by interactive tools, numerous development programs and teammates who want to help you grow. We see value in helping each other be our best and that extends to empowering our employees in their career journeys. - You will learn and adopt best practices like writing clean and reusable code using TDD, pair programming and design patterns. - You will use and advocate for continuous delivery practices to deliver high-quality software as well as value to end customers as early as possible. - You will work in collaborative, value-driven teams to build innovative customer experiences for our clients. - You will create large-scale distributed systems out of microservices. - You will collaborate with a variety of teammates to build features, design concepts and interactive prototypes and ensure best practices and UX specifications are embedded along the way. - You will apply the latest technology thinking from our Technology Radar to solve client problems. - You will efficiently utilize DevSecOps tools and practices to build and deploy software, advocating devops culture and shifting security left in development. - You will oversee or take part in the entire cycle of software consulting and delivery from ideation to deployment and everything in between. - You will act as a mentor for less-experienced peers through both your technical knowledge and leadership skills. Qualifications - You have experience using one or more development languages (Java, Kafka, Quarkus and React) with experience in Object-Oriented programming. - You can skillfully write high-quality, well-tested code and you are comfortable with Object-Oriented programming. - You are comfortable with Agile methodologies, such as Extreme Programming (XP), Scrum and/or Kanban. - You have a good awareness of TDD, continuous integration and continuous delivery approaches/tools. - Bonus points if you have working knowledge of cloud technology such as AWS, Azure, Kubernetes and Docker. Requirements - You enjoy influencing others and always advocate for technical excellence while being open to change when needed. - Presence in the external tech community: you willingly share your expertise with others via speaking engagements, contributions to open source, blogs and more. - You’re resilient in ambiguous situations and can approach challenges from multiple perspectives. Benefits - There is no one-size-fits-all career path at Thoughtworks: however you want to develop your career is entirely up to you. - Your career is supported by interactive tools, numerous development programs and teammates who want to help you grow. - We see value in helping each other be our best and that extends to empowering our employees in their career journeys. Company Description Thoughtworks is a dynamic and inclusive community of bright and supportive colleagues who are revolutionizing tech. As a leading technology consultancy, we’re pushing boundaries through our purposeful and impactful work. For 30+ years, we’ve delivered extraordinary impact together with our clients by helping them solve complex business problems with technology as the differentiator. Bring your brilliant expertise and commitment for continuous learning to Thoughtworks. Together, let’s be extraordinary.

• Collaborate with business stakeholders, analysts, and project leads • Translate business needs into technical specifications and data models • Design and develop interactive Qlik Sense dashboards and reports • Install, configure, and manage Qlik Sense Enterprise environments • Write complex SQL queries and procedures to analyze large datasets