USA - Engineer II
USA - Engineer II
Posted on :
14-07-2025
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1 Vacancy
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Job Description
Description:
JOB DESCRIPTION:
**This project will run through 12/2026**
**Workers can be remote/hybrid but must be local and able to come into the office at least three days a week**
Job Title: Sr. Engineer Disposables R&D Sustaining
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.
Are Workers Project-based **This project will run through 12/2026**
**Workers can be remote/hybrid but must be local and able to come into the office at least three days a week**
Job Title: Sr. Engineer Disposables R&D Sustaining
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.
Additional Details
- Does the position allow for the worker to be virtual/remote : No
- Shore Options Available for this Position : Onshore Only
- Direct or Indirect : Indirect
- Kronos Worker : no
- Shift : USA-1
Employment Type
Full-time
Key Skills
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