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Principal Engineer Disposables R&D, Sustaining

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Jobs via Dice Dice is the leading career destination for tech experts at every stage of their careers. Our client, Pyramid Consulting, Inc., is seeking the following. Apply via Dice today!

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.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy

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Seniority level

Seniority level

Mid-Senior level Employment type

Employment type

Contract Job function

Job function

Engineering and Information Technology Industries

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