See all jobs in Bridgewater NJ
Job Location: Bridgewater, NJ
Our client is the North American division of a well established manufacturer of Medical Devices, seeking a Technical Writer - Product Engineer for their line of Dialysis Equipment. The Technical Writer - Product Engineer will be responsible for supporting the process of bringing new products to the North American market. Technical writing for documentation for new and existing products will be a critical part of this position. Responsibilities of the Technical Writer - Product Engineer include:
service manual, quick reference guide, troubleshooting manual, parts manual, maintenance
- Develop technical documentation for new and existing products including but not limited to
- Develop technical procedures for the internal and external biomed technicians supporting safe
and effective use of the product.
- Develop work instructions for the internal technical & clinical team on the use, troubleshooting
and repair of the existing and new products.
- Support the process of bringing new products to the North American market including assistance
in creation of technical documentation for successful 510(k) submission.
- Confirm that the design complies with applicable standard regulations and FDA guidelines.
Assist in creation product safety, performance testing protocols and technical reports.
- Actively participate in the risk management process ensuring consistent and detailed risk analysis
- Ensure that the risk assessment with required testing for the type of device has been conducted.
- Ensure that the technical documentation conforms with appropriate standards, such as 21 CFR,
FDA harmonized, ISO, IEC, (ISO 10993, IEC 62304, IEC 60601-2-16, and more) for 510k
submissions.\Understand the nature of the IEC safety, biocompatibility, human factors engineering, software
Requirements for Product Engineer - Dialysis Equipment include:
- Working knowledge, proficiency and understanding of hemodialysis systems is strongly preferred
- AA or Bachelor's degree in biomedical engineering or related field
- 5 or more years of experience in engineering or as a biomedical technician
- Advanced mechanical and electrical skills with ability of troubleshooting hydraulic systems
- Experienced in developing and providing technical training, including technical writing
- Ability to work within a team and as an individual contributor in a fast-paced, diverse team
- Strong verbal and written communication skills with ability to effectively interact at multiple levels
within the organization.
- Ability to travel approximately 20-25%
- Ability to support hemodialysis systems in the field with expert level of proficiency in
troubleshooting and repair in the field as needed
How To Apply:
You will be directed to another website for application instructions.