Human Factors Study Lead - Combination Products Kymanox is hiring a (Contract) Human Factors Study Lead - Combination Products to join our team.
Responsibilities include:- Leading specific client consulting efforts, including product lifecycle strategy consulting, supporting client development teams as primary HF/UE resource, planning and executing HF/UE activities and studies.
- Supporting the human factors analysis of new and existing medical products using sound research methodologies, best practices, and regulatory requirements.
- Supporting the planning, execution, and reporting of human factors research studies throughout the US and internationally.
- Conducting data collection, analysis, and documentation to support regulatory.
- Leading the execution of human factors consulting projects for multi-national and start-up companies. Compliance with regulatory agencies, especially FDA, is mandatory.
- Designing, developing, implementing, moderating, data analyzing, and report writing of human factors activities; including formative and validation usability studies.
- Participating 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.
- Coaching and supporting team members in areas of technical expertise and practical implementation.
- Operating within defined QMS and business procedures.
- Identifying and evaluating process improvement opportunities.
- Always 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 (or relevant degree). Advanced Degree (e.g., Masters, PhD) preferred.
Experience:- Minimum 3 years' relative experience with executing and moderating HF studies (formative or validation).Minimum 3 years' relative experience with Medical Devices and/or Combination Products.
- Knowledge of IEC 62366-1, FDA guidance on Human Factors, and ISO 14971.Proficiency in MS Office Suite.
- Experience with product design and development, quality, and regulatory submissions is a plus.
- 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 include interpersonal, coaching, and facilitation skills.
- A friendly, professional demeanor and ability to excel in a team-oriented environment.
- Strong attention to detail.
Travel:
Up to 50% travel. 30-50 hours per week when traveling. 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. Kymanox is headquartered in Research Triangle Park (RTP), North Carolina and operates additional offices in King of Prussia, Pennsylvania, Switzerland, and Germany. Kymanox employees and contractors live and work around the world primarily in the USA and Europe. 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.
