Hi Hope you are doing well Please share the resume for the below mentioned position
DHF Remediation for Catheters San Diego, California Job Description: This position is responsible to investigate, complete, and maintain Design History files of varieties of Catheter products. The responsibilities of this position include evaluation of current product documentation available to determine if sufficient information is available, do Gap assessment, plan of action to fulfill the gaps accordance with the FDA's QSR Regulations, ISO 13485, the MDD and departmental requirements as appropriate. Additionally this position will execute the documents required such as Risk management files, Test plans, execute the testing required to have the verification and Validation reports required etc. The position holder needs Medical Device Catheter product design experience. He/she must also be: Accountable for setting own work direction and completing work tasks. Able to manage the end to end process of design history file requirements. Able to fill out Medical Device Reports (MDR) decision trees when needed. Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information. Primary Skills KNOWLEDGE, SKILLS & EXPERIENCE Critical Knowledge: Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.is highly preferred. Bachelor's degree in relevant science with > 5 years of experience in a medical device Class II or Class III industry. Strong analytical skills Strong verbal and written communication skills. Critical Skills: Should know about Design history files required for Class II and Class III Devices. Product design experience, Proven experience of making FMEA, Risk management files etc.. Verification and Validation experience of Catheters. Should have himself made the Verification and validation protocols and test reports. Measurement system analysis experience. Critical Experience: Experience in similar environment in Medical Device Industry Preferably Class II and Class III Medical device industry. Patient Safety Orientation, Experience with analyses of product development and manufacturing engineering. Secondary Skills Testing and documentation, reverse Engineering Any specific industry experience Medical Disposables Education Bachelor's degree in Engineering Thanks & Regards Prabhdeep Singh Call: 816.399.4677 Email: [email protected]<mailto:[email protected]> Skype: [email protected] Agelix Consulting LLC 8595 College Blvd #135, Overland Park, KS, United States 66210 [email protected]<mailto:[email protected]> [Logo of Agelix Consulting] NOTICE: This electronic mail message and any attached files are confidential. The information is exclusively for the use of the individual or entity intended as the recipient. If you are not the intended recipient, any use, copying, printing, reviewing, retention, disclosure, distribution or forwarding of the message or any attached file is not authorized and is strictly prohibited. If you have received this electronic mail message in error, please advise the sender by reply electronic mail immediately and permanently delete the original transmission, any attachments and any copies of this message from your computer system. Thank you. -- You received this message because you are subscribed to "rtc-linux". Membership options at http://groups.google.com/group/rtc-linux . Please read http://groups.google.com/group/rtc-linux/web/checklist before submitting a driver. --- You received this message because you are subscribed to the Google Groups "rtc-linux" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. For more options, visit https://groups.google.com/d/optout.
