- ICU Medical (San Diego, CA)
- …Device Software position manages the Quality activities related to ICU Medical Device Software Development, Testing, and Release, within Device ... the organization's expert within a particular discipline .Working knowledge of Medical Device Regulations .Quality compliance, audit, and investigation skills… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- … science. Key Responsibilities: + Develop comprehensive test plans and test cases for medical device software , firmware, and algorithms based on product ... developing test protocols, and implementing test automation + Experience in medical device software testing required + Experience with software… more
- Merck (Rahway, NJ)
- …Management - ISO 14971, EU MDR, Medical Electrical Equipment - EN 60601, Medical Device Software Standard - IEC 62304, ISO 11608 Needle-based injection ... methods as needed in tech transfer or lifecycle. + Experience with medical device development with understanding of Design Controls (21 CFR 820.30) + Familiarity… more
- Randstad US (St. Paul, MN)
- …you'll have the chance to work with a team of engineers building code to deliver medical device software to the cloud. You will work with Infrastructure as ... application concepts + Familiarity with system and security design principles of medical device back-end software + Working knowledge of Waterfall, Agile,… more
- Kelly Services (Warren, NJ)
- …(dependent on experience) **Job Overview:** The **Quality Engineer** is the subject matter expert for Software as a medical device SAMD and/or software ... as an accessory/component to a medical device , and ensures the software is compliant with all regulations. This role oversees implementation of the project… more
- Fresenius Medical Center (Lawrence, MA)
- As a medical device Software Development Engineer in Fresenius Medical Care's Home business unit, you will be able to make a valuable contribution every ... supervision. + Highly motivated and energetic. Passion for creating high quality medical device software and systems. + Experience and familiarity with IEC… more
- Fresenius Medical Center (Lawrence, MA)
- As a medical device Software Test Engineer in Fresenius Medical Care's Home business unit, you will be able to make a valuable contribution every day to ... supervision. + Highly motivated and energetic. Passion for creating high quality medical device software and systems. + Experience in development of… more
- Medtronic (Mounds View, MN)
- …both your technical breadth and business acumen to support the newly approved therapy medical device software and participate in the design and development ... role requires strong technical and leadership skills to support the embedded software for newly release medical device within the CRDN Group. The Senior … more
- Philips (Plymouth, MN)
- …of complex medical systems._ + _Supporting the creation and review of all medical device software documentation including Software Development Plans, ... ISO 14971, Risk management for medical devices and IEC 62304 Medical Device Software ._ + _Identifying, promoting, and supporting processes and tools for… more
- STERIS (Pomaria, SC)
- …Systems Architecture, Software Design, Hardware interface and Connectivity solutions for medical device software . + Define Requirements and Design ... including trace and track systems, and interfacing with embedded software for management and control of interconnected medical...Drying Cabinets, Storage and other IPT equipment in Steris medical device segment. Duties + Provide technical… more
- BioFire Diagnostics, LLC. (San Jose, CA)
- …related field. + Extensive software development experience, with a strong emphasis on medical device software or regulated fields. + Proficiency in C#, ... a healthcare setting. + Knowledge of FDA regulations and standards related to medical device software development will be an advantage. + Excellent written… more
- STERIS (Pomaria, SC)
- …in Engineering General or Science Required Experience + 2+ years related experience in medical device software development and/or test. Preference for MS in ... will be responsible for the testing of embedded firmware, C, C++, & C# medical device applications, and Enterprise software with complex SQL database and web… more
- J&J Family of Companies (Santa Clara, CA)
- …Mentor members of the engineering staff to conform to Industry Standards for Medical Device Software (IEC 62304) **Qualifications** **Education:** + Minimum ... and technical specialists are on the forefront of technology in the medical device industry. The Principal Software Systems Engineer will make vital… more
- Omnicell, Inc. (Cranberry Township, PA)
- … engineering role + Understanding of electro-mechanical (robotic) systems + Healthcare or Medical Device software development experience + Experience with ... Engineer 3 is responsible for developing, maintaining, and supporting our device software development and product environment. This position works within… more
- Hologic (San Diego, CA)
- …and IVD Product Testing; + Molecular diagnostic technology and nucleic acid amplification; + Medical device software life cycle process, IEC 62304; + Writing ... and test software and hardware requirements for a Class II Medical Device . + Write technical test protocols and technical reports. + Perform Verification and… more
- Teleflex (Chelmsford, MA)
- …standards for safety and security, eg MISRA, CERT-C etc. * Knowledge of medical device software development lifecycle and regulatory requirements related ... field & 5 years of hands-on experience in embedded software , preferably in medical devices * MS...multi-threaded programming and debugging; * Experience integrating hardware and software , I/O, device drivers, emulator & debugger;… more
- Stryker (Sacramento, CA)
- …and security practices in healthcare software . + Previous work on FDA-regulated medical device software . + Experience with AI/ML + Experience as ... lives, with a passion for researching and developing new medical device products. As an engineer at... devices. You'll collaborate with cross-functional teams to create software that enhances patient care and medical … more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …will play a critical role in ensuring the quality and compliance of our medical device software through adherence to regulatory standards and implementation ... FDA Part 820 Design Controls and other regulatory requirements applicable to medical device software development. + Ensure software development… more
- Actalent (Osseo, MN)
- …Skills: software project management, Software Engineering leadership, Medical Device Software , mobile application development, cloud solution ... Firmware Development, PMP, Software PM, MS Project, Firmware, Software Development, Medical Device Additional Skills & Qualifications: - Develops… more
- Actalent (Raleigh, NC)
- … Software Engineer, you will play a pivotal role in the development of our medical device software systems. You will drive software quality efforts, ... exciting opportunity to contribute to the development of life-changing medical devices. Skills: C++, Embedded software , Linux,.... Knowledge and experience of rules and regulations for medical device development (IEC 62304 knowledge a… more
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