Chipton Ross is seeking a

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

JOB SUMMARY
Technical lead for DHF structure within sustaining engineering for disposable medical devices.

BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
o Experience in managing medical device product support activities and change controls.
o Experience managing supplier relations & records management.
o Experience managing design output strategies across different product families.
o Experience managing design transfers from R&D to manufacturing.
o Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
o Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
o Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
o Ability to train and coach others from technical expertise.
o Self-directed, resourceful, and able to manage multiple priorities.
o Strong interpersonal, communication, collaboration and influencing skills.
o Ability to read, write and comprehend English.

POSITION RESPONSIBILITIES:
o Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.
o Manage change controls from initiation through execution.
o Lead the creation and maintenance of design history files.
o Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
o Schedule, budget, and lead engineering project with minimal guidance.
o 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.
o 5 - 8 years of related experience in Class II or Class III disposables medical product development.

REQUIRED EDUCATION:
Relevant Bachelor's degree required

WORK HOURS:
First Shift, Full Time

Job Number: 214982
Job Location: Plymouth, MN
Rate: Up to $58.59 DOE
Duration: 12 months
Input Date: 08/13/2025
Last Updated: 08/13/2025

Firm Name: CHIPTON ROSS
Attention: Patricia Serge
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: pserge@chiptonross.com
Website: www.chiptonross.com

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