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...
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...
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...
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 inductive (H&R, FTA) methods, the outcomes of these analyses will inform to the system design/architecture responsible Supports..., or secondly IEC 61508 standard. Prefer a good understanding of embedded Software engineering and Hardware engineering domains...
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...
for humanity. Learn more at https://www.jnj.com Job Function: R&D Product Development Job Sub Function: Industrial Design... usability regulations and standards. Knowledge of the ISO 14971 and IEC 62304 are a plus. Fluent in English. German...
& engineering, UX, R&D, quality, regulatory, and global IT to embed security into every stage of the product lifecycle. Key..., and Compliance teams to meet industry standards (FDA, IEC, NIST) Design, document or improve key processes for the service function...
environment such as ISO 9001, 13485 or FDA. Familiar with design for Safety (IEC 61508) and design for Security (IEC 62443... that you can make the best of both worlds. About Us: The company's continual leading edge in R&D and manufacturing ensure the...
performance metrics for reporting to senior leadership. Compliance & Standards: Ensure compliance with IEC 62304, FDA software... and present quality findings to executive management and R&D leadership;monitor and resolve ongoing issues. Process Improvement...