Technical Writer - Product Development (Medical Device)
Description
Essential Functions:
- Collaborates with Research & Development, Manufacturing and Marketing teams to accurately document test methods, technical reports, labels, and other design file documents for specific market products.
- Performs independent literature research, analyzes data and conducts interviews for in-depth white papers and other scientific/technical documents.
- Conducts extensive literature and industry research, analyzes results and compiles information into meaningful reports for various audience types.
- Performs interviews with scientific and technical staff, and translates information onto detailed documents.
- Creates all essential documentation for technical device design histories, manufacturing BOMs and routers.
- Works closely with regulatory and quality staff to ensure product documentation supports regulatory and quality standards.
- Works with project and product managers to document product alignment with business strategy.
- Designs and creates protocols, technical reports, test methods, manufacturing instructions, project planning documents and labeling documents.
- Designs marketing documents, IFUs and labels according to the Quality System.
- Supports project managers with action items, project planning documentation, and coordinates with the project team for successful launch of product.
- Creates Standard Operating Procedures (SOPs) for new procedures; maintains and updates current SOPs.
- Creates technical submission files and coordinates with regulatory team on submission/approval process.
- Collaborates with regulatory team to assist with international submissions; creates additional required documents as new regulations arise in different countries.
- Coordinates, validates, and assists with documenting test results.
- Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications:
- Bachelor’s Degree in Engineering, Science or a related technical field.
- Minimum of four (4) years of direct documentation experience in the medical device, software or other technical industry.
- Knowledge of 21 CFR 820.
- Knowledge of current US and International regulations as it pertains to documentation.
- Knowledge of current US and International standards governing medical devices.
ABOUT US
ORB Innovations is a London-based startup making waves in the world of contact and combat sports. With a passion for innovation, ORB makes Smart Mouthguards that protect athletes teeth AND track their fitness, performance and wellness, providing valuable data to help them train smarter and push further... What's a Smart Mouthguard? Imagine a Fitbit, in a mouthguard!
ORB's products are the first and only of their kind, from heart-pumping beats to head-turning impacts, we've got these athletes covered with a wearable that's tailored to their sport.
Founded in 2017, ORB has spent over 5 years tirelessly working to bring this groundbreaking technology to market. Now, as ORB expands its team, join us in bringing the future of sports technology to athletes everywhere.
THE INTERVIEW PROCESS
Our process involves three stages:
- Resume Review & Short List.
- Initial Call (Depending on the role, a take home task may also be requested).
- Final Interview.
Our average process takes approximately 2-3 weeks, but we always work around your availability.
You will have the chance to speak to our recruitment team at various points during your process but if you do have any specific questions or want to talk through reasonable adjustments ahead of or during your application, please contact us at [email protected].
WHAT'S IN IT FOR YOU
We're a hardware enabled sports analytics startup with an expanding passionate team, collaborating and creating extraordinary physical & digital products that have the potential to make a significant difference to our customers lives. If you love sports and technology, this is where the two meet!
There are loads of ways we help ORB-ians do the best work. We often review and enhance our benefits, but here's a brief overview of what we offer right now. If you'd like more information on any of them, just ask!
You can see a full list of employee benefits at https://orbsport.com/pages/careers.
EQUAL OPPORTUNITY STATEMENT
We are actively creating an equitable environment for every ORB-ian to thrive.
One of our priorities is to promote diversity and inclusion, ensuring that we provide ample support for all our employees to grow within the company. Embracing diversity in all its forms and fostering an inclusive environment are essential to our ethos.
As an equal opportunity employer, we consider all applicants for employment without any bias based on ethnicity, religion, sexual orientation, gender identity, family or parental status, national origin, veteran status, neurodiversity status, or disability status.