in ISO13485:2016 would be an asset. Familiarity with IEC 60601 and IEC 62304 is an asset. Processing, investigating... and maintaining calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas. Knowledge...
of all performed procedures in assisting in implementation of ISO / IEC 17025:2005 in the laboratory Maintain the good laboratory... that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory...
-related issues as necessary. Keep current of MDR regulations and best practices for medical device human factors (e.g. IEC.... NVivo, atlas.ti, SPSS/SAS/JMP/Stata/R). Ability to travel domestically and potentially internationally (up to 40...
processes in compliance with current FDA guidance and IEC 62304. Work closely with Clinical Engineering and Product Management... testing. Mentor senior managers, managers, and individual contributors. Maintain cross-functional alignment within OTTAVA R...
, product specifications and standard requirements (UL, CSA, NOM, CCC and IEC). Create and execute verification & validation... and evaluation methods (UL/ CSA/NOM/ IEC/ CCC/ ANSI). Knowledge of CAE (Ex, Structural, Thermal, Kinematics...
. Senior R&D Engineer – Atherectomy Interventional Cardiology Division Maple Grove, MN Onsite About This Role...: This opportunity is for a Senior R&D Engineer supporting sustaining engineering Atherectomy projects within the Interventional...
of assigned product family to help ensure product compliance to applicable regulatory standards (e.g. UL, IEC, ANSI) Creates... specifications and standard requirements (UL, CSA, NOM, CCC and IEC) Supports the creation and execution of verification...
of all performed procedures in assisting in implementation of ISO / IEC 17025:2005 in the laboratory Maintain the good laboratory... that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory...
: Lead the global Scrum Teams through the SDLC for medical devices following IEC 62304/82304. Facilitate the team’s progress.... From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves...
Primes and customers and improving processes. The successful candidate will have a sound working knowledge of ISO/IEC 17025.... Responsibilities Maintenance and scope extension of all accreditations (e.g. ISO/IEC 17025 and Nadcap), Prime approvals...