Reporting directly to the ID/IF Manager, the Senior Human Factors Engineer is primarily responsible for user-centred research activities related to the design and development of novel medical devices.
As part of the Industrial Design and Human Factors (ID/HF) group, the Senior Human Factors Engineer firmly understands the product development process from concept ideation to manufacturing.
With a focus on graphical and physical user interfaces, this position supports product development teams throughout the product development lifecycle.
The role-holder is an individual contributor within a dynamic and creative team environment.
The Senior Human Factors Engineer will also participate in brainstorming events, presenting usability solutions, evaluating potential use errors for risk, performing usability assessments to inform design, and contributing to verifying and validating medical devices.
This opportunity is a hybrid work arrangement from our Toronto, ON office.
Plan, scale document, and conduct human factors activities for innovative medical device development.
Provide leadership and mentorship with the Human Factor team efforts on projects and be client-facing from the outset of a project to transfers.
Support early-stage development with research, user studies and usability evaluations to identify user needs, support design optimization and identify potential use errors.
Develop requirements related to use, user interactions, and human performance.
Evaluate and assess risks related to product use.
Design usability evaluations to ensure user interface requirements are met and risk controls pertaining to use have been applied and are effective.
Analyze data, report results, and recommend improvements based on Human Factors guidelines and best practices.
Support process improvement and Human factors-related initiatives within the business.
Responsible for project health and financial reporting, including ownership of BOM costing and quoting.
5+ Years of experience as a Production Manager, Product Management or Project Engineering roles with
~ Bachelor’s degree in human Factors, Industrial Design, UX Research or Design, Biomedical Engineering, or other related discipline.
~ Experience in planning, conducting, and reporting on Human Factors Usability Validations.
~ Experience with Human Factors/Usability in medical device development preferred.
~ Familiarity with existing IEC Usability standards, AAMI Human Factors standards and FDA Human Factors Guidance.
~ Experience with Human Factors or User-centered design methodologies, including generative research, user needs assessment, design concepts, and usability evaluations in support of product development.
~ Experience with risk management activities applied by Human Factors to medical devices (e.g., UEA, AFMEA, UFMEA, URA techniques). Experience interacting with FDA and other regulatory bodies in the context of new product approval submissions and/or audits desired.
~ Strong interpersonal and communication skills, both written and verbal, in English.
~ Excellent data analysis skills.
~ Why work at Star
Fish Medical:
The Office offers shower facilities for midday runs or biking to work, and there is a bike share station within a 5-minute walk to the Office.
~ Free parking on-site and around the premises.
Thanks in advance for your interest in StarFish Medical
About StarFish Medical
Is Canada’s leading Medical Device Design service provider with a full complement of design, development, and manufacturing services in Victoria and Toronto.
We successfully partner with innovative companies (both large and small) to create breakthrough products for several medical specialty areas.
Our work environment received Canada’s Most Admired Corporate Culture awards for 2021 & 2022, recognizing best-in-class cultures that have helped enhance performance and sustain a competitive advantage.
Studies have shown that women and people of colour are less likely to apply for jobs unless they meet every qualification.
At StarFish Medical, we are dedicated to building a diverse, inclusive, and authentic workplace.
If you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway.
You may be just the right candidate for this or other roles Please apply through the StarFish Medical Portal.
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We also seek innovative and dedicated professionals from a wide range of backgrounds to complement our fulltime team on a contracting basis.
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