Overview
On Site
Full Time
Skills
Documentation
Budget
Policies and Procedures
Product Support
Records Management
Research and Development
Manufacturing
Design Controls
ISO 13485
Quality Management
ISO 9000
Risk Management
Medical Devices
Innovation
Management
Communication
Collaboration
English
Mechanical Engineering
Biomedical Engineering
Product Development
Job Details
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 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.
- dhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
- 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.
- dvanced 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.
- bility to train and coach others from technical expertise.
- Self-directed, resourceful, and able to manage multiple priorities.
- Strong interpersonal, communication, collaboration and influencing skills.
- bility 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.
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