Senior Engineer – Disposables R&D, Sustaining

Immediate need for a talented Senior Engineer – Disposables R&D, Sustaining. This is a 12+ months contract opportunity with long-term potential and is located in Plymouth, MN(Hybrid). Please review the job description below and contact me ASAP if you are interested.
 
Job ID: 25-77916
 
Pay Range: $35 - $36/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key 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.

 
Key Requirements and Technology Experience:  

• Key skills; Engineer, Medical device, ISO, FDA
• 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.

 

Our client is a leading IT Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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