- Stryker (Portage, MI)
- …Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) ... maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards. + Demonstrated strong understanding… more
- Terumo Medical Corporation (Elkton, MD)
- …Strong writing, mathematics, and statistics skills + Demonstrated working knowledge of key medical device related standards including 21 CFR 820 (Quality Systems ... of experience in an engineering and/or scientific environment + Minimum of 2 years of experience in a regulated industry ( medical device industry preferred) more
- Terumo Medical Corporation (Elkton, MD)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... Preferred: Knowledge of some DFX processes and tools and their application in medical device product development. Preferred: Ability to define, write and perform… more
- Globus Medical, Inc. (Audubon, PA)
- …and components for medical or robotic applications + Familiarity with medical device development, including regulatory and safety considerations, is highly ... the latest tools and methodologies in C++ development, robotics integration, and medical device software, with opportunities for continuous learning and career… more
- Terumo Medical Corporation (Caguas, PR)
- …Experiences** + High School Degree or equivalent (GED), is a must.Previous experience working in a medical device or pharmaceutical industry, preferred. ... + Performs quality inspections through the assembly process to ensure compliance with regulatory standards and product specifications. Document all sub assembly… more
- GE HealthCare (Waukesha, WI)
- …and Machine Learning techniques. + Hands-on experience integrating AI Models into medical device products + Experience in developing AI inference pipelines ... design and implementation throughout development cycles. + **Quality & Compliance ** : Apply technical expertise to ensure the quality...for medical device . **Desired Characteristics / Technical Expertise**… more
- Penn Medicine (Philadelphia, PA)
- …working with medical hardware, software and equipment products + Understand medical device usage within a health system environment + Experience working ... for low, medium and high risk equipment, utilizing a strong understanding of medical device integration and networking. + Correctly and efficiently applies basic… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Manufacturing is responsible for managing the onboarding manufacturers of sourced finished medical device products to ensure products meet current Good ... Manufacturing Practices, applicable medical device regulatory requirements, and for supporting...Olympus and the suppliers. + Ensure regulatory and contractual compliance in accordance to FDA, ISO 13485, ISO 9001,… more
- Stryker (San Jose, CA)
- …Engineer** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) ... strong technical skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in… more
- Compass Group, North America (Chicago, IL)
- …management initiatives across assigned hospital accounts. This role focuses on medical device integration, project execution, and capital equipment coordination ... DUTIES AND RESPONSIBILITIES + Project Leadership: Plan, coordinate, and oversee medical device integration projects, ensuring timely completion, stakeholder… more