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R&D Engineer Sustaining, Medical Devices (Disposables) - Plymout...
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R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN
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R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN
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Jobs via Dice R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN
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R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN
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Jobs via Dice Get AI-powered advice on this job and more exclusive features. Dice is the leading career destination for tech experts at every stage of their careers. Our client, Cube Hub, Inc., is seeking the following. Apply via Dice today!
Job Title: Principal R&D Engineer Sustaining, Medical Devices (Disposables)
**Workers can be remote/hybrid but must be local and able to come into the office at least three days a week**
Job Location: Plymouth, MN
Job Duration: 12 months
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 supplier relations & records management.
Experience managing design output strategies across different product families.
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 Full-time Job function
Job function Engineering and Information Technology Industries Software Development Referrals increase your chances of interviewing at Jobs via Dice by 2x Get notified about new Research And Development Engineer jobs in
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Join to apply for the
R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN
role at
Jobs via Dice R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN
2 days ago Be among the first 25 applicants Join to apply for the
R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN
role at
Jobs via Dice Get AI-powered advice on this job and more exclusive features. Dice is the leading career destination for tech experts at every stage of their careers. Our client, Cube Hub, Inc., is seeking the following. Apply via Dice today!
Job Title: Principal R&D Engineer Sustaining, Medical Devices (Disposables)
**Workers can be remote/hybrid but must be local and able to come into the office at least three days a week**
Job Location: Plymouth, MN
Job Duration: 12 months
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 supplier relations & records management.
Experience managing design output strategies across different product families.
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 Full-time Job function
Job function Engineering and Information Technology Industries Software Development Referrals increase your chances of interviewing at Jobs via Dice by 2x Get notified about new Research And Development Engineer jobs in
Plymouth, MN . Greater Minneapolis-St. Paul Area $99,461.00-$128,329.00 1 week ago Maple Grove, MN $90,000.00-$120,000.00 1 month ago Plymouth, MN $108,000.00-$155,000.00 3 days ago Arden Hills, MN $82,600.00-$156,900.00 1 month ago Blaine, MN $70,000.00-$75,000.00 2 months ago Bloomington, MN $100,000.00-$150,000.00 3 weeks ago Maple Grove, MN $76,000.00-$144,400.00 1 month ago Maple Grove, MN $82,600.00-$156,900.00 1 month ago Plymouth, MN $60,000.00-$120,000.00 2 days ago Machine Learning Development Engineer position in Maple Grove, MN
Plymouth, MN $75,300.00-$150,700.00 5 days ago Plymouth, MN $124,000.00-$168,000.00 2 days ago Machine Learning Engineer – Medical Imaging
Arden Hills, MN $82,600.00-$156,900.00 1 month ago Arden Hills, MN $76,000.00-$144,400.00 1 month ago Greater Minneapolis-St. Paul Area $125,000.00-$140,000.00 2 weeks ago Maple Grove, MN $122,100.00-$232,000.00 3 weeks ago Minneapolis, MN $95,000.00-$137,000.00 1 month ago Eagan, MN $108,500.00-$201,500.00 1 week 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