in their lifetime. What You’ll Do: As the Sr Hardware Electronics Design Engineer, you will be a part of the R&D team focused on the... that complies with regulatory requirements of the FDA, UL and TUV (specifically those related to IEC, EMC, CISPR, etc). Design...
technical support and training to customers and internal teams. Lead R&D projects, including planning, budgeting, and logistics... (ICEA, AEIC, IEC, IEEE). Proficiency with design and analysis software (Cymcap, Comsol Multiphysics, SolidWorks, AutoCAD...
adherence. Lead cross-functional collaboration to synchronize requirements across R&D, clinical, and regulatory teams. Conduct... in a dynamic environment. Join a team of 5 reporting into the Sr. Director of R&D. The Successful Applicant: 5+ years...
with family of standards for electrical safety of medical devices IEC/EN/UL 60601-1 Experience in R&D environment, delivering...
+ years industry experience Quality Assurance, R&D, or Regulatory Affairs in Medical Device or Pharmaceutical Industries.... Experience with Medical Device Quality Systems (21 CFR 820, ISO-13485, and EU MDR) Strong familiarity with ISO-14971 and IEC...
leadership within a vibrant and high-performing R&D team that is redefining the treatment of structural heart disease. The... Engineering or similar. Familiarity with ISO 13485, IEC 60601-1, 60601-1-2 family of standards. Familiarity with ARM Cortex-M...
leadership within a vibrant and high-performing R&D team that is redefining the treatment of structural heart disease. The... Engineering or similar. Familiarity with ISO 13485, IEC 60601-1, 60601-1-2 family of standards. Familiarity with ARM Cortex-M...
closely with local and/or international Quality Assurance, Regulatory Affairs, Manufacturing, Operations, R&D, Sales... (V&V), Process Validation (PV), and Test Method Validation (TMV) Medical Electrical Equipment requirements and testing per IEC 60601...
and cybersecurity initiatives. The Sr. Regulatory Affairs Specialist will work with software, algorithm development R&D, quality... regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC...
plans, operation and maintenance SOPs. · Supporting lab R&D team with mechanical design of custom laboratory apparatus... requirements. Understanding of controls engineering, PLC/PAC controllers and IEC 6113103 languages (ladder, FBD, structured text...