Technical Writer
Create a structure for functional specifications for all products. This involves working with the various disciplines in Engineering and Quality to define the proper structure to fit the regulatory and technical needs.
Write the Functional Specifications for each product based on inputs from the Product Requirements Document, Regulatory, Quality and Engineering.
Conduct detailed reviews of documents with stakeholders to gain alignment.
Assure that all requirements are clear and harmonized with the Jama system.
Publish and maintain these documents in PLM.
Work with the technical team to coordinate the writing of Module
Specifications based on the Functional Specifications. Engineering will write the core of these MS documents, the Requirements Engineer will assure that they are edited and refined to meet documentation standards.
The Requirements Engineer will maintain the MS requirements in the Jama system as well.
Detailed Skillset and Responsibilities:
1.A solid understanding of the medical device development life cycle, including design validation, process validation, labeling, sterilization, and post-market surveillance.
2. A thorough knowledge of the regulatory requirements for class-3 medical devices, such as the FDA's premarket approval (PMA) process, premarket notification (510(k)), unique device identification (UDI) system, and adverse event reporting
3.A proficiency in using tools and methods for requirements engineering, such as elicitation techniques, modeling languages, traceability matrices, verification and validation techniques, and change management.
4.An ability to communicate effectively with different stakeholders, both verbally and in writing.
5.An attention to detail and a problem-solving mindset.
6.A willingness to learn new technologies and standards.
Additional Specific Skills:
1. Define the scope and objectives of the medical device project based on the customer's needs and expectations.
2. Elicit, analyze, document, and manage the functional and non-functional requirements of the medical device using appropriate tools and methods.
3. Ensure that the requirements are clear, complete, consistent, testable, traceable, and aligned with the regulatory standards and guidelines.
4. Review and approve the design specifications and test plans of the medical device based on the requirements.
5. Coordinate with other engineers, developers, testers, quality managers, and regulators to ensure that the medical device meets the requirements throughout the development life cycle.
6. Monitor and control the changes in the requirements and assess their impact on the project schedule, budget, quality, and risk.
7. Coordinate with Design Assurance during verification and validation activities to ensure that the medical device conforms to the requirements and performs as expected.
8. Work with the Clinical and Regulatory teams to support the preparation and submission of regulatory documents such as PMA applications, 510(k) notifications, UDI labels, and adverse event reports.
Great hourly rate + Additional benefits + Free NFL / NBA / MLB game ticket for successful candidates!
For more details about rates and more information about the project, please contact Tommy on
Phone: +1 617-752-3681