We are seeking a talented technical writing professional who is passionate
about the medical device/software industry to join our Engineering team.
You will be part of a creative group working on challenging problems, while
learning from others in an agile and dynamic environment. The Technical
Writer is responsible for creating and ensuring documentation for design
documents, scientific validation documents, technical documents and
instructions for use of products, meet the applicable standards and
Provide technical writing in product design documentation and
technical documents as necessary for all aspects of medical
device and software development to meet the ISO 13485 / US FDA
Quality System Regulations and other relevant standards and
Work with Engineering, QA and Regulatory teams to gain an
understanding of the products to develop the design control
documentation and coordinate the product user guides and development
of related documentation.
Work with Regulatory Affairs team on product submissions and
associated reporting including clinical evaluation reports (CERs)
and risk management reports as per ISO 14971 standard.
Work with Clinical Application Specialists and Product Support
teams on product deployment related documents, including
preparation, execution, and supporting publications.
Be part of project design team consisting Product Management
/ QA / Engineering to understand the project specific documentation
requirements and timeline.
Identify and report documentation related issues found during
verification and validation testing and follow up on the
Work closely with software developers, application specialists and
product managers to understand user scenarios, requirements, and
typical usage workflows and ensure these are captured in the relevant
design documentation and instructions for use.
Gather the scientific and clinically significant new features of the
product and document relevant algorithms, reference scientific
papers and validation reports.
2+ years of technical writing experience in medical device or
software or any related industry.
Software proficiency in Microsoft Office and other desktop / online
Proficiency in desktop and online documentation publishing tools.
Professional educational credentials on Technical Writing.
Previous experience in Medical Device or Software related
Experience working with regulated medical products or previous
medical device experience is preferred.
Other international language skills will be a plus.
A minimum of diploma in technical writing or related field.
About the Company
Circle Cardiovascular Imaging Inc. is a Calgary based company that develops
analytics software for the evaluation of cardiovascular MR and CT images.
Circle Operates worldwide and has installations of their products
cmr42®, cvi42, and report42 in over
25 countries. Circle’s goal is to contribute to quality in cardiovascular
imaging and research, maximizing the achievable benefit for patients by
enabling healthcare providers to accurately and effectively analyze
Circle Cardiovascular Imaging Inc. holds globally recognized
ISO 13485:2003 certifications from the prestigious
British Standards Institution (BSI). This certification
includes Standards Council of Canada (SCC) endorsement
Canadian Medical Device Conformity Assessment System
(CMDCAS) scheme. In addition to ISO 3485:2003, the company quality
system is established and maintained to comply with
European Medical Device Directive 93/42/EEC and
US FDA Quality System Regulations,
21 CFR Part 820.
How To Apply
While we thank all those who apply, please note that we will only be
contacting those selected for an interview. No phone calls or unsolicited
agency referrals please. Only applicants who are authorized to work in
Canada will be considered for this position.
Please send Résumé or CV with a cover letter Attention of Shirantha Samarappuli
to the following:
||+1 403 338 1895
Circle Cardiovascular Imaging Inc.
250, 815 8th Avenue SW