Human Factors Study Lead (Contract)
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 hiring a Human Factors Study Lead (Contract) to join our team.
Responsibilities:
- Support the planning, execution, and reporting of human factors research studies throughout the US and internationally.
- Conduct data collection, analysis, and documentation to support development of regulatory strategy, road-map for medical device and combination product clients.
- Design, development, implementation, moderation, data analysis, and report writing of human factors activities; including formative and validation usability studies.
- Support the human factors analysis of new and existing medical products using sound research methodologies, best practices, and regulatory requirements
- Support client consulting efforts for multi-national and start-up companies, including, but not limited to product lifecycle strategy, supporting client development teams as primary HF/UE resource, planning and executing HF/UE activities and studies.
- Compliance with 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 medical products and devices to professional and lay users.
- Coach and support team members in areas of technical expertise and practical implementation.
- Execute duties in a manner aligned to core values.
- 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 engineering or science with coursework or work-related experience in medical sales, business development, marketing, or communications. Advanced Degree (e.g., Masters, PhD) preferred.
Experience:
- Minimum 3 years' relative experience with Medical Devices and/or Combination Products.
- Minimum 3 years’ relative experience with executing and moderating HF studies (formative or validation)
- Knowledge of IEC 62366-1, FDA guidance on Human Factors, and ISO 14971
- Proficiency in MS Office Suite.
Desired Aptitude and Skill Set:
- Ability to prioritize, plan, perform and communicate activities both in written and verbal form.
- Ability to read and understand published regulations.
- Ability to present analysis and evaluation results in a cohesive, understandable, and actionable format to cross-functional teams and decision-makers.
- Ability to communicate well at all levels of the organization.
- Ability to work effectively cross-functionally.
- Strong problem-solving skills.
- Strong prioritization skills.
- Excellent communication skills including interpersonal, coaching, and facilitation skills.
- A friendly, professional demeanor and ability to excel in a team-oriented environment.
- Strong attention to detail.
- Ability to travel in the US.