51 to 58 of 58 IEC 62304 Jobs

the verification and validation of Capital Equipment, including hardware, software, firmware, and systems of systems interdependencies. Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485. Strong leadership, relationship building, and team building skills. Demonstrated ability to mentor and coach others in analysis More ❯

or III medical devices. Proficient in requirements management tools such as JAMA, DOORS, or similar. In-depth knowledge of standards such as 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304. Strong analytical skills with a systems-thinking approach to solving complex technical challenges. Excellent verbal and written communication skills to effectively convey complex technical More ❯

Your Responsibilities BS Degree in an engineering discipline or related technical and/or life-science field Familiarity/comfort with Systems Engineering work in accordance with ISO/IEC/IEEE 15288 Note: we are NOT seeking IT Systems Administrators/Engineers 3-5 (or more) years' experience in the medical device (or similarly-regulated - e.g., aerospace) industry … Demonstrable success in supporting one or more strategic, multi-faceted projects to completion Familiarity/comfort with issue management (per ISO 14971 and IEC 62304 for those with medical device backgrounds), in service of development work bug documentation/dispositioning Baseline computer programming skills, inclusive of the ability to review embedded software, digital logic, and hardware description language … Profile BS Degree in an engineering discipline or related technical and/or life-science field 5+ years experience as a Systems engineer working in accordance with ISO/IEC/IEEE 15288 Note: Stated explicitly, we are NOT seeking IT Systems Administrators/Engineers 3+ years experience in the medical device (or similarly-regulated - e.g., aerospace) industry Demonstrable More ❯

external information security assessments. Qualifications Essential 5+ Years experience in QA/RA within a regulated medical device environment ISO 13485, QMS/ISMS implementation and oversight, ISO 14971, IEC 62304 Internal and external auditing experience Familiarity with EU MDR, US 21 CFR Part 820 Strong communication skills with the flexibility to engage effectively with diverse audiences System … cause analysis, risk assessment, documentation, project leadership, software development familiarity Strategic thinker, self-starter, cross-functional collaborator, efficiency-driven, pragmatic Preferred Experience hosting audits and managing CAPAs ISO 27001, IEC 62366, MDSAP Certified ISO 13485 internal auditor or lead auditor Broader global regulatory experience A confident and approachable communicator who can effectively challenge ideas while driving progress Training others More ❯

Management Systems (QMS). Education/Experience: Bachelor's degree and 3+ years of practical experience in the medical device industry. Must have experience with ISO 13485:2016 and IEC 62304 Knowledge of FDA's General Principles of Software Validation Guidance Familiarity with standards such as GAMP5 Risk management knowledge for the medical device industry (ISO More ❯

Supply, DMM). Ability to read and understand data sheets and schematics. Experience with configuration management and issue tracking and resolution. Experience with medical device software life cycles processes (IEC 62304) is preferred. Ability to meet deadlines and work in multidisciplinary project teams. More ❯

in compliance with environmental, health and safety related site rules, policies or governmental regulations. Solid understanding of federal and international medical device regulations, such as FDA QSR, ISO 14971,62304, and 13485, and EU MDR. More ❯

to verify each requirement, execute the testing, and write the final report. Additionally,Client would like someone that has experience with the Medical Device Software Lifecycle , specifically with the IEC 62304 Software Lifecyle Standard. CLient not looking for someone to develop software, just experience with it such that they can manage our software design history files Experience with More ❯