Sr. Engineer - Disposables R&D, Sustaining - Hybrid

Title: Sr. Engineer - Disposables R&D, Sustaining - Hybrid

Mandatory skills:

Disposables R&D, Sustaining,
disposables medical product development,
medical device design outputs, receiving, inspection,
medical device product support, change control management,
FDA Design Controls, ISO 13485 Quality Management Systems, ANSI, AAMI, ISO 14971 Medical Devices, Application of Risk Management,
3rd party supplier documentation, design specifications, labeling, design drawings, peritoneal dialysis disposable sets,
design transfer, design history files, design control procedures,
change control assessments, general safety rules, company policies, procedures, FDA, international regulations, guidance

Description:

Essential 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.

VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at for any complaints, comments and suggestions.

Contact Details :

VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008