Johannes Österberg

Scaling and streamlining operations. Outsourcing and supplier quality. Comprehensive management of production, contract manufacturing, logistics and installed base change management of medical breakthrough technology. Contract and agreement negotiations, cost of goods sold (COGS), Design transfers for NPI and installed base, design for manufacturing, BOM and technical specifications, design and process verification and validation. Internal, supplier, and notified body audits. Cross-functional teamwork in changes and NPI programs including notified body, fda and regulatory documentation. Part of team granted with succesfull FDA IDE approval.

Worked around the clock with global suppliers, contract manufacturers and high profile government contacts to ramp up ventilator production with contract manufacturers under US government Defense Production Act during the start of covid-19 and simultaneous global component shortage. Co-operated directly with high profile individuals with US government agency background and innovative companies (Meta R&D labs) to reach the goal to secure critical components in shortage. https://www.federalregister.gov/documents/2020/04/01/2020-06969/delegating-additional-authority-under-the-defense-production-act-with-respect-to-health-and-medical Managed and succesfully lowered COGS for category of Class II medical device accessories: ECG cables and leadwires, hemodynamic IBP, Temp and CO accessories. Filters and anestehesia circuits and accessories.

Vyaire Medical (now Airlife) was spin-off from Becton Dickinson covering medical device accessory portfolio for GE Healthcare and other large international companies. NPI program leadership and execution: design, verification, validation, regulatory applications (FDA and EU MDD/MDR). Leading installed base supplier change programs for lowering COGS. Expat in Germany performing B2B consulting for contract manufacturing company to elevate them to FDA 21 CFR 820 level https://connect.myairlife.com/resources/LIT-20477-C1_DuoTherm_Rev2.pdf Leading NPI program of releasing 100+ product SKU's to submit multiple 510(k)'s for FDA class II medical devices: https://connect.myairlife.com/resources/BRO-20033-C1%20Multi-Link%20X2%20Rev1.pdf

NPI program leadership and execution: design, verification, validation, regulatory applications (FDA and EU MDD/MDR). Leading installed base supplier change programs for lowering COGS.

Responsible of the verication and validation of Vital Signs Devices R&D team. Team develops medical accessories for anesthesia & ventilation, temperature management and gas monitoring applications. Leading the testing activities by evaluating the product specifications, creating verification plans, performing the in-house testing, testing outsourcing, writing verification documents and managing the verification equipment. Creating intellectual property and involved in many line-extension and NPI projects.