Senior Human Factors Engineer - Combination Products

Job Description:
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
Kymanox is seeking a Senior Human Factors Human Factors Engineer to lead and execute Human Factors Engineering (HFE) and Usability Engineering (UE) programs that support the development of safe, effective, and user-centered medical devices and combination products. This role is focused on providing strategic human factors leadership, regulatory guidance, user interface development support, and end-to-end execution of HF/UE activities across the product lifecycle.
You will collaborate with cross-functional client teams, regulatory and engineering stakeholders, research participants, and fellow consultants to deliver high-quality human factors solutions that improve patient and user outcomes. We are looking for a seasoned leader who is passionate about medical product development, possesses deep expertise in human factors and usability engineering, and enjoys mentoring others, solving complex challenges, and identifying opportunities to advance both client success and Kymanox's service offerings.
At least 7 years of HF Experience with Combination Products and Medical Devices are Required.
Responsibilities:
Support Kymanox Human Factors (HF) services in the development of HF strategies and execution of overall Human Factors engineering and Usability Engineering (HFE/UE) Programs with a focus on combination products and medical devices.
Serve as subject matter expert for Kymanox in HFE/UE, Human Factors Regulatory Strategy, and Risk Management
Serve as technical lead for concurrent programs including combination products and medical devices
Lead specific client program efforts, including, but not limited to product lifecycle strategy consulting, supporting client development teams as primary HFE/UE resource, planning and executing HFE/UE activities and HF studies.
Support the HFE analysis of new and existing combination products and medical devices using sound research methodologies, best practices, and regulatory requirements
Support the planning, execution, and reporting of human factors research studies throughout the US and internationally
Design, development, protocol implementation, moderation, observation, data analysis, and report writing of human factors activities; including formative and validation studies.
Lead the execution of human factors projects for large/medium/small and start-up companies.
Compliance with global regulatory agencies, especially FDA is mandatory.
Participation as a consultant-team member working with other like-minded professionals with a passion to support our clients and provide safe and effective combination products and medical devices to professional and lay users.
Coach and support team members in areas of technical expertise and practical implementation.
Operate within defined QMS and business procedures.
Identify and evaluate process improvement opportunities.
Always be looking and listening for new opportunities to broaden and deepen our services within the medical products industry.
Educational Background:
The ideal candidate will have a Bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering. Advanced Degree (e.g., Masters, PhD) preferred
Experience:
At least 7 years of experience in:
Working as a Human Factors Engineer/Leader in combination products, or medical device industries.
Leading multiple HF programs for combination products, or medical devices
Developing documentation such as use task analysis (UTA), use-related risk analysis (URRA)/use failure mode and effects analysis (UFMEA) in alignment with regulatory expectations
Generating HF formative and validation protocols and reports, HFE/UE summary report ) in alignment with regulatory expectations
Moderating and observing formative and validation HF Studies.
Providing expert advice/recommendation on user interface including instructions for use, labeling, and device design.
Desired Aptitude and Skill Set:
Detail-oriented
Strong organizational skills and verbal/written communication skills
Highly motivated self-starter with a sense of ownership and willingness to learn
Thrive in a fast-paced, growing, and dynamic work environment
Ability to form partnerships with internal stakeholders

Skills
Data Analysis, Process Improvement, Risk Management, Documentation