management, traceability, and design controls. Ensure compliance with medical device standards (ISO 13485, IEC 60601..., etc.) and regulatory guidelines. Support design transfer from R&D to production under ISO 13485 and FDA guidelines. Innovation...
Engineering Senior Manager to lead our MRI Safety Engineering team within the R&D organization. This leadership role is critical... Partner with other R&D functional teams to ensure MRI safety requirements are captured, implemented, and verified. Drive...
and ensure compliance for the same. Work with R&D and Manufacturing Engineering in the completion of system/software... 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485. Advanced computer skills, including statistical/data...
. The VP of Research and Development (R&D) is responsible for defining and executing the company’s innovation and product... a strong R&D governance model (Product Development Process stage gates) ensuring disciplined portfolio management and timely...
their effectiveness and appropriateness What You’ll Work On Represent R&D as electrical hardware technical core team lead guiding... Familiarity with IEC 60601 family of standards Familiarity with Altium or other Electrical CAD tools Experience with digital...
development. Experience verifying medical devices controlled by software. Familiarity with FDA guidance and standards (IEC 62304.... From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves...
Where you come in: You will actively participate as a core team member of the R&D Quality Assurance Engineering team You will provide guidance on IEC 62304... and quality system regulation and standards such as IEC 62304, ISO 13485, ISO 14971, 21 CFR 820. We are responsible for various...
Job Title Senior R&D Electrical Engineer Job Description The Organization: Vanderlande is a market-leading... realization of fast, reliable, and eficient automation technology. The products and processes developed by the R&D group include...
Collaborate cross-functionally with sales, product management, R&D, and operations to develop application solutions, support... of hazardous location classifications, protection methods (Ex d, Ex e, Ex i), and global standards (NEC, IEC, API) Experience...
Manager to lead our Electronics Design Group within a surgical equipment R&D organization. This role is responsible... leadership, along with a thorough understanding of IEC 60601 standards, FDA and EU design control regulations, and risk...