Overview
On Site
USD 30.00 per hour
Full Time
Skills
Recruiting
Health Care
Creo
FMEA
Mechanical Engineering
Biomedical Engineering
Product Development
Six Sigma
DFSS
Training
Inspection
Product Support
Research and Development
Manufacturing
ISO 13485
Quality Management
ISO 9000
Risk Management
Medical Devices
Innovation
Collaboration
Communication
Attention To Detail
Organized
Management
English
Documentation
Change Control
IT Management
Design Controls
Policies and Procedures
Job Details
Date Posted: 07/11/2025
Hiring Organization: Rose International
Position Number: 485371
Industry: Healthcare
Job Title: Engineer Disposables and Sustaining
Job Location: Plymouth, MN, USA, 55441
Work Model: Onsite
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 12
Min Hourly Rate($): 30.00
Max Hourly Rate($): 35.00
Must Have Skills/Attributes: Creo, DFMEA, Medical device, Sterilization
Experience Desired: Experience in Class II or Class III disposables medical product development (5 yrs)
Required Minimum Education: Bachelor's Degree
Job Description
Education:
BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
Experience:
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.
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.
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.
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
Hiring Organization: Rose International
Position Number: 485371
Industry: Healthcare
Job Title: Engineer Disposables and Sustaining
Job Location: Plymouth, MN, USA, 55441
Work Model: Onsite
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 12
Min Hourly Rate($): 30.00
Max Hourly Rate($): 35.00
Must Have Skills/Attributes: Creo, DFMEA, Medical device, Sterilization
Experience Desired: Experience in Class II or Class III disposables medical product development (5 yrs)
Required Minimum Education: Bachelor's Degree
Job Description
Education:
BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
Experience:
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.
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.
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.
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.