Cube Hub Inc.
Engineer – Disposables R&D, Sustaining
Cube Hub Inc. - Minneapolis, Minnesota, United States, 55400
Work at Cube Hub Inc.
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Overview
Principal Sustaining Engineer – Disposable Medical Devices
Principal Sustaining Engineer – Disposable Medical Devices
1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by Cube Hub Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$50.00/hr - $54.00/hr Direct message the job poster from Cube Hub Inc. **This project will run through 12/2026** **Workers can be remote/hybrid but must be local and able to come into the office at least three days a week** TEMP - HIRE Job Title: Principal Engineer – Disposables R&D, Sustaining Summary: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Essential Duties and Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. • Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets. • Manage change controls from initiation through execution. • Lead the creation and maintenance of design history files. • Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders. • Schedule, budget, and lead engineering project with minimal guidance. • Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. • Experience in managing medical device product support activities and change controls. • Experience managing design transfers from R&D to manufacturing. • Advanced 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. • Ability to train and coach others from technical expertise. • Self-directed, resourceful, and able to manage multiple priorities. • Strong interpersonal, communication, collaboration and influencing skills. • Ability to read, write and comprehend English. Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred. • 5 - 8 years of related experience in Class II or Class III disposables medical product development. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cube Hub Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Sustaining Engineer” roles.
Minneapolis, MN $75,000.00-$85,000.00 1 week ago Minneapolis, MN $75,000.00-$85,000.00 1 week ago Elk River, MN $64,000.00-$74,000.00 1 month ago Edina, MN $64,680.00-$101,640.00 1 week ago Eden Prairie, MN $65,000.00-$80,000.00 4 days ago Ramsey, MN $77,000.00-$115,000.00 5 days ago Eden Prairie, MN $85,000.00-$115,000.00 1 day ago Manufacturing & Process Engineer/Technician
Champlin, MN $80,000.00-$115,000.00 1 week ago Plymouth, MN $75,300.00-$150,700.00 6 days ago Manufacturing Engineer II - Interventional Products
Quality Manufacturing Engineer - Medical Device (Entry/Junior Level)
Greater Minneapolis-St. Paul Area 3 weeks ago Rogers, MN $74,100.00-$129,600.00 20 hours ago Plymouth, MN $63,600.00-$101,800.00 1 week ago Minneapolis, MN $74,100.00-$129,600.00 20 hours ago Quality Engineer II — Medical Device (Hybrid — Maple Grove, MN) Contract
Bloomington, MN $63,835.00-$91,290.00 8 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Principal Sustaining Engineer – Disposable Medical Devices
1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by Cube Hub Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$50.00/hr - $54.00/hr Direct message the job poster from Cube Hub Inc. **This project will run through 12/2026** **Workers can be remote/hybrid but must be local and able to come into the office at least three days a week** TEMP - HIRE Job Title: Principal Engineer – Disposables R&D, Sustaining Summary: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Essential Duties and Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. • Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets. • Manage change controls from initiation through execution. • Lead the creation and maintenance of design history files. • Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders. • Schedule, budget, and lead engineering project with minimal guidance. • Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. • Experience in managing medical device product support activities and change controls. • Experience managing design transfers from R&D to manufacturing. • Advanced 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. • Ability to train and coach others from technical expertise. • Self-directed, resourceful, and able to manage multiple priorities. • Strong interpersonal, communication, collaboration and influencing skills. • Ability to read, write and comprehend English. Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred. • 5 - 8 years of related experience in Class II or Class III disposables medical product development. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Cube Hub Inc. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Sustaining Engineer” roles.
Minneapolis, MN $75,000.00-$85,000.00 1 week ago Minneapolis, MN $75,000.00-$85,000.00 1 week ago Elk River, MN $64,000.00-$74,000.00 1 month ago Edina, MN $64,680.00-$101,640.00 1 week ago Eden Prairie, MN $65,000.00-$80,000.00 4 days ago Ramsey, MN $77,000.00-$115,000.00 5 days ago Eden Prairie, MN $85,000.00-$115,000.00 1 day ago Manufacturing & Process Engineer/Technician
Champlin, MN $80,000.00-$115,000.00 1 week ago Plymouth, MN $75,300.00-$150,700.00 6 days ago Manufacturing Engineer II - Interventional Products
Quality Manufacturing Engineer - Medical Device (Entry/Junior Level)
Greater Minneapolis-St. Paul Area 3 weeks ago Rogers, MN $74,100.00-$129,600.00 20 hours ago Plymouth, MN $63,600.00-$101,800.00 1 week ago Minneapolis, MN $74,100.00-$129,600.00 20 hours ago Quality Engineer II — Medical Device (Hybrid — Maple Grove, MN) Contract
Bloomington, MN $63,835.00-$91,290.00 8 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr