Chipton Ross is seeking a

Description:
Chipton Ross is seeking a Sr. Engineer - Disposables R&D, Sustaining for a contract opportunity in Plymouth, MN.

BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
• 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.

POSITION 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.

PREFERRED QUALIFICATIONS (DESIRED SKILLS/EXPERIENCE):
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.

REQUIRED EDUCATION:
Relevant Bachelor's degree required

WORK HOURS:
First Shift, Full Time

Job Number: 214983
Job Location: Plymouth, MN
Rate: Up to $40.42 DOE
Duration: 12 months
Input Date: 08/13/2025
Last Updated: 09/28/2025

Firm Name: CHIPTON ROSS
Attention: Robert Davis
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: rdavis@chiptonross.com
Website: www.chiptonross.com

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