Engineer Disposables and Sustaining
Engineer Disposables and Sustaining
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Requirements:
- 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract