Principal Engineer
Principal Engineer
Posted on :
15-07-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
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.
Responsibilities:
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.
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 a 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.
- 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.
- 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.
Employment Type
Full-time
Key Skills
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