Workers can be remote/hybrid but must be local and able to come into the office at least three days a weekDescription:Job Title: Sr. Engineer – Disposables R&D, SustainingEssential Duties and Responsibilities:Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.Create, modify, and maintain design history files.Perform change control assessments.Work closely with project manager and technical lead to achieve project commitments.Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.Qualifications:Experience working with external manufacturing partners and supplier relations.Experience creating and modifying medical device design outputs including receiving and inspection criteria.Experience in medical device product support and change control management.Experience in design transfer from R&D to manufacturing.Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.Strong collaboration, verbal and written communication skills.Strong attention to detail, organized, and able to independently manage multiple priorities.Ability to read, write and comprehend English.Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.3 - 5 years of related experience in Class II or Class III disposables medical product development.Design for Six Sigma (DFSS) training or certification preferred.Notes:Shift USA-1Workers can be remote/hybrid but must be local and able to come into the office at least three days a weekVIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:Job Title: Sr. Engineer – Disposables R&D, SustainingEssential Duties and Responsibilities:Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.Create, modify, and maintain design history files.Perform change control assessments.Work closely with project manager and technical lead to achieve project commitments.Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.Qualifications:Experience working with external manufacturing partners and supplier relations.Experience creating and modifying medical device design outputs including receiving and inspection criteria.Experience in medical device product support and change control management.Experience in design transfer from R&D to manufacturing.Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.Strong collaboration, verbal and written communication skills.Strong attention to detail, organized, and able to independently manage multiple priorities.Ability to read, write and comprehend English.Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.3 - 5 years of related experience in Class II or Class III disposables medical product development.Design for Six Sigma (DFSS) training or certification preferred.Notes:Shift USA-1Workers can be remote/hybrid but must be local and able to come into the office at least three days a week
(Please ensure email matches your resume email)
(document types allowed: doc/docx/rtf/pdf/txt) (max 2MB)
By submitting this form, you are consenting to the VIVA team contacting you via Phone/Email