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 Associate Human Factors Engineer to join our team.
Responsibilities:
- Support the planning, execution, and reporting of human factors research studies throughout the US and internationally including design, development, implementation, moderation, data analysis, and report writing of human factors formative and validation
- Support the human factors analysis of new and existing medical products using sound research methodologies, best practices, and regulatory requirements
- Support specific client consulting efforts, including, but not limited to product lifecycle strategy consulting, supporting client development teams as primary HF/UE resource, planning and executing HF/UE activities and studies
- Conduct data collection, analysis, and documentation to support regulatory
- Compliance with regulatory agencies, especially FDA is mandatory.
- 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 a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.
Experience:
- 0-2 years’ relative experience with executing and moderating Human Factors studies for Medical Devices and/or Combination Products.
- Demonstrate general aptitude and knowledge of Human Factors engineering in the Pharmaceutical, Biotechnology and/or Medical Device/Combination Products industries
- Proficiency in MS Office Suite.
- There are no required external training or certifications for this role.
Desired Aptitude and Skill Set:
- 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
- Ability to prioritize, plan, perform and communicate activities both in written and verbal form in a timely manner or per project’s timeline expectations.
- Ability to communicate well at all levels of the organization and to implement constructive feedback from project teams and clients
- Excellent communication skills including interpersonal, coaching, and facilitation skills including prompt responses to team’s requests, and ensuring open communications to team’s support and escalations when encountering challenges when needed.
- Ability to present analysis and evaluation results in a cohesive, understandable, and actionable format to cross-functional teams and decision-makers. Strong problem-solving skills.
- A friendly, professional demeanor and ability to excel in a team-oriented environment and support with on-site set up and take down.
- Ability to work effectively cross-functionally with strong prioritization skills and time management skills.
- Ability to translate published regulations into development of HF documentations..
Travel:
Up to 50% travel. 30-50 hours per week when traveling
Career Development:
The position may evolve over time and responsibilities will be added. Since Kymanox is a growing company, there will be ample opportunities for advancement – both within the currently defined role, with other groups, and roles to be defined in the future.
Compensation:
Base compensation will be commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for bonus program after 6 months of outstanding work.
Benefits:
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
About Kymanox:
Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC and we have offices in Pennsylvania along with Boston.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
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