Overview
On Site
Full Time
Skills
Documentation
IT Management
Policies and Procedures
Mechanical Engineering
Biomedical Engineering
Product Development
Six Sigma
DFSS
Training
Inspection
Product Support
Change Control
Research and Development
Manufacturing
Design Controls
ISO 13485
Quality Management
ISO 9000
Risk Management
Medical Devices
Innovation
Collaboration
Communication
Attention To Detail
Organized
Management
English
Job Details
Responsibilities:
- Create new 3rd party supplier documentation including design specifications, labelling, 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.
- 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.
- 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.
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