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...
and collaboration. Collaborate with Medical Quality, R&D, Vendors, Manufacturing, Lab Operations, Legal, Regulatory and other cross... Design & Development (Design Controls) Supports R&D and cross-functional teams in applying design controls from feasibility...
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...
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...
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...
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...
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...
knowledge about electrical safety standards and codes in the HVAC/R product area (examples: IEC/UL/CSA 60335-2-40, 60335-2-34... Conditioning and Ventilation (HVAC/R) products at CSA Group to provide senior technical leadership within the Technical Management...
and document PV and P&R tests (Burst, cyclical and endurance) to engineering specifications (new releases, engineering changes... and update guidelines Support other functional areas Familiarity with Bosch values and relevant standards (ISO, IEC, etc.) TPM...