Principal Engineer – Disposables R&D, Sustaining

Immediate need for a talented Principal Engineer – Disposables R&D, Sustaining. This is a 17+months contract opportunity with long-term potential and is located in Plymouth, MN (Hybrid). Please review the job description below and contact me ASAP if you are interested.
 
Job ID:25-77915
 
Pay Range: $50 - $51/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan.
 
Key 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.

Key Requirements and Technology Experience:

• Key Skills: 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.
• DHF (design history files) structure within sustaining engineering for disposable medical devices.
• 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.
• 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.

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
 
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