USA - Principal Engineer
USA - Principal Engineer
Posted on :
14-07-2025
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1 Vacancy
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Job Description
Title:- Principal Engineer Disposables R&D Sustaining)
Hybrid/remote work allowed; must be local and able to be onsite at least 3 days per week.
Work Location:- Plymouth MN
Duration:- 12 Month
- Serve as the technical lead for Design History File (DHF) structure within sustaining engineering for disposable medical devices.
- Manage new third-party supplier documentation strategies for peritoneal dialysis disposable sets.
- Oversee change controls from initiation through execution.
- Lead the creation and maintenance of design history files.
- Coordinate and communicate R&D efforts with global cross-functional stakeholders.
- Schedule budget and lead engineering projects with minimal guidance.
- Ensure adherence to design control procedures safety rules company policies and FDA/international regulations.
Qualifications:
- Bachelor s degree in Mechanical Plastics or Biomedical Engineering (Master s preferred).
- 5 8 years experience in Class II or Class III disposable medical product development.
- Advanced knowledge of FDA Design Controls and ISO 13485 QMS.
- Experience with ANSI/AAMI/ISO 14971 risk management for medical devices.
- Proven ability to manage product support activities change controls supplier relations and design transfers.
- Strong initiative innovation and best practices implementation.
- Excellent training coaching interpersonal communication and collaboration skills.
- Ability to manage multiple priorities in a self-directed and resourceful manner.
Work Location:- Plymouth MN
Duration:- 12 Month
- Serve as the technical lead for Design History File (DHF) structure within sustaining engineering for disposable medical devices.
- Manage new third-party supplier documentation strategies for peritoneal dialysis disposable sets.
- Oversee change controls from initiation through execution.
- Lead the creation and maintenance of design history files.
- Coordinate and communicate R&D efforts with global cross-functional stakeholders.
- Schedule budget and lead engineering projects with minimal guidance.
- Ensure adherence to design control procedures safety rules company policies and FDA/international regulations.
Qualifications:
- Bachelor s degree in Mechanical Plastics or Biomedical Engineering (Master s preferred).
- 5 8 years experience in Class II or Class III disposable medical product development.
- Advanced knowledge of FDA Design Controls and ISO 13485 QMS.
- Experience with ANSI/AAMI/ISO 14971 risk management for medical devices.
- Proven ability to manage product support activities change controls supplier relations and design transfers.
- Strong initiative innovation and best practices implementation.
- Excellent training coaching interpersonal communication and collaboration skills.
- Ability to manage multiple priorities in a self-directed and resourceful manner.
Employment Type
Full-time
Key Skills
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