Heikki Karma Email & Phone Number

Helsinki, Fi

Helsinki Metropolitan Area

Building the corporate capabilitiesI was instrumental in Oura’s strategic entry into the medical device market, supporting strategy development and building core capabilities. Led recruitment of specialized talent and advanced our consumer device processes to meet medical regulatory standards.Program management Managed Oura’s first Software as a Medical Device (SaMD) program, Fertile Window, ensuring full regulatory compliance and seamless cross-functional collaboration. Fertile Window was launched in October 2024.

Helsinki Metropolitan Area

Program manager for Oura Ring 4I established the cross-functional Oura Ring 4 team and outlined the workstreams and timelines for Product, Hardware, Firmware, Science, Software, Operations, and Marketing. Additionally, I developed the program's operating mechanisms, which include cross-functional synchronization, reviews, risk management, and reporting. I effectively coordinated the team's efforts throughout the discovery phase.Process developmentI led and architected the establishment of Oura's New Product Development process within the Corporate PMO. This process facilitates lifecycle management of comprehensive end-to-end solutions, from concept development through productization to go-to-market (GTM). In the phase model, all cross-functional deliverables are organized within a structured phase review discipline.

Helsinki

Managing the program that developed a revolutionary system which will resolve most wicked issue in healthcare and significantly improve patient outcomes and healthcare providers efficiencies. Direct full-time development engineer staffing was around 20 people and with the cross-functional members and third-party service providers, there were more than 40 professionals working in my team globally.Program management role entailed- negotiating program scope to ensure strategic and financial goals were attained. This included forecasting and management of multiple options of operational and capital expenses as well as labor to maximize ROI and NPV- developing and implementing strategies for mentoring, motivating and coordinating global team- managing system design, strategy, budget, schedule and multi-functional team for a multinational project. I had the ultimate responsibility for completion of project- developing and retaining design team, ensuring each member having goals which supported one another and were aligned with strategic goals- process development to improve design controls and to keep them better adherent to daily work- driving the clinical investigation excellence as an integral part of the development phase- agreements negotiations, statements of work, and design specifications with manufacturers, service providers and external OEM suppliers

Helsinki Area, Finland

I led the Vyaire top priority consumable NPI project, which designed, developed and introduced a very large portfolio of ECG accessories to global markets. The project team consisted of 20+ professionals on both US and in Finland and the manufacturing was ramped-up in Asia. The project was completed and products were launched on time, within the budget and per the original scope. The project filed and got clearances on two FDA 510(k) applications: K162432 and K163316.

Helsinki, Finland

I led the engineering project that ensured the Carefusion’s fastest growing product line to maintain the growth rate, by filling the gaps both on SKUs and compliance perspective. The outcome was succesfull and the planned growth rate remained within the planned level for several years forward.

Helsinki, Finland

Lead Program Integrator of a Patient monitoring system device.- Leading the core team of 4 electronic engineers and 4 mechanical engineers.- Negotiating program scope to ensure strategic and financial goals are attained in a given schedule.- Coordinating the device development integration between Helsinki, Finland and Milwaukee, US design facilities.

Helsinki

Leader for two new pulse oximetry sensor development projects, FDA cleared with K101871, K103802 and K132696.Holistic project team leading responsibility in new product introductions. I contributed to the entire development lifecycle:- user requirements evaluation,- generation of product’s performance specification,- supplier selection,- product’s design development,- design verification and validation, - production ramp-up and global release. Project staffing: global: 20+, local 10.I facilitated the team's work through the entire development lifecycle, scoping and scheduling the project, planning the activities, ensuring adequate resourcing, facilitating reviews with global peers and cross functional teams, facilitating workshops, taking care of the reporting to management, and managing the supplier relations.

Helsinki

Product development and design changes

Helsinki

Mechanics designing of injection molded and machined components.

M. Sc, Engineering

Exchange Student, Mechanical Engineering, M.Sc.