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Job Requirements of Senior Engineer – Disposables R&D, Sustaining:
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Employment Type:
Contractor
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Location:
Plymouth, MN (Onsite)
Do you meet the requirements for this job?
Senior Engineer – Disposables R&D, Sustaining
Careers Integrated Resources Inc
Plymouth, MN (Onsite)
Contractor
Job Title: Senior Engineer – Disposables R&D, Sustaining
Location: Plymouth, MN 55441
Duration: 12 Months+ (possibility of extension)
Pay Rate: $46.50/hr. on W2
Essential Duties and Responsibilities:
Qualifications:
Experience and/or Background:
Location: Plymouth, MN 55441
Duration: 12 Months+ (possibility of extension)
Pay Rate: $46.50/hr. on W2
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.
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