About The RoleCollaborate with a team to create technical documentation, specification writing, technical &engineering specifications, product manuals, IFUs, service and operation manuals. Work closely with engineers and scientists at different levels to assist in deploying world changing mechanical/electronic systems. Keep technical documentation on projects according to ISO 9001/13485 quality management system requirements.
- Work with engineers and physicists to review drawings and compile specifications that can be sent to procurement.
- Support various tasks to document design, testing, requirement traceability and inspection.
- Maintain documents and drawings in an organized manner according to Document Control and Quality Assurance principles
About You- Minimum 3 years of experience in technical writing, prefer medical background.
- Excellent Technical writing skills for a variety of mechanical, electrical, and various other high-tech products.
- Practical knowledge of concepts of Quality Assurance and Document Control.
- Ability to work with others and seek out necessary information to make effective Part Specifications.
- Experience working with industrial vendors to get component information, design specifics, quality documents, testing certifications, etc.
- Hands-on experience in managing technical documentation according to ISO 9001 quality management system requirements.
Software Knowledge and Skills Required:- Adobe Software
- Ability to utilize a database or write macros to optimize data entry is a plus
- Basic knowledge of CAD systems for mechanical design (AutoCAD, SolidWorks).
- Available to work flexible and extended hours if needed
- Good verbal and communication skills
- Ability to work independently as well as a member of a team
- Ability to cooperate in a fast-paced, team environment
- Ability to liaise with others to achieve company goals
- Organizational skills to include project documentation, SOP's, and training
- Knowledge of the medical industry quality systems (ISO 13485)
- Mechanical and/or electrical drawing checking
- Manufacturing Instruction Writing
- Familiarity with equipment testing (Verification & Validation) and documentation
Education- Required: B.S. in journalism, English, or communications.
- Preferred: B.S. as engineering, computer science, or medicine.
At TAE Technologies, we consider a wide range of factors when making compensation decisions including but not limited to skill sets; experience and job-related knowledge, training; licenses and certifications, and other business and organizational needs. The total compensation package for this position may also include other elements depending on the position offered (non-Sr., Sr., Lead or Manager). The compensation range for these roles are $85,000 - $110,000.
