Job Details

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18-month contract in Plymouth, MN

Job will run through 12/2026

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

Hourly pay rate is: $ 58.59