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Technical Writer - Product Engineer
Apple & Assoc. Inc
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:
  • Develop technical documentation for new and existing products including but not limited to
service manual, quick reference guide, troubleshooting manual, parts manual, maintenance
procedures, etc.
  • 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
    documentation updates.
  • 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
  • Working knowledge, proficiency and understanding of hemodialysis systems is strongly preferred
Requirements for Product Engineer - Dialysis Equipment include:
  • 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.
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