Katalyst CRO
Principal Engineer Disposables R&D, Sustaining
Katalyst CRO, Minneapolis, Minnesota, United States, 55447
Principal Engineer – Disposables R&D, Sustaining
Responsibilities
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.
Requirements
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
Mid-Senior level
Employment type
Contract
Job function
Industries
Pharmaceutical Manufacturing
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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.
Requirements
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
Mid-Senior level
Employment type
Contract
Job function
Industries
Pharmaceutical Manufacturing
Get notified about new Principal Engineer jobs in Plymouth, MN.
#J-18808-Ljbffr