(Part-time Contract) Human Factors Study Lead - Combination Products

Kymanox; United States; On-site; USD 83,000 - 152,000; Part time

Job summary

Kymanox is seeking a Contract Human Factors Study Lead to support combination product programs across the US and international teams. You will plan and execute HF/UE activities, lead studies, and ensure regulatory compliance.

Ideal candidates have 3+ years in HF studies, knowledge of IEC 62366-1, FDA HF guidance, ISO 14971, and strong communication skills. Travel up to 50% is required.

Qualifications

• Minimum 3 years of HF studies execution and moderation.
• Experience with Medical Devices or Combination Products.
• Knowledge of IEC 62366-1, FDA HF guidance, ISO 14971.

Responsibilities

• Lead client HF/UE efforts, planning and executing studies.
• Support human factors analysis of medical products using sound methodologies and regulatory requirements.
• Plan and report HF studies across the US and internationally.
• Conduct data collection, analysis, and documentation to support regulatory submissions.
• Lead projects for multi-national and startup companies, ensuring FDA compliance.
• Design and implement HF activities including formative and validation studies.
• Collaborate with consulting teams to deliver safe and effective medical devices.
• Coach team members and operate within QMS and SOPs.
• Identify process improvements and seek new opportunities.
• Explore opportunities to broaden services in medical products.

Skills

Human factors

Regulatory knowledge

Communication

Education

Bachelors in Engineering or Science

Masters/PhD preferred

Tools

MS Office Suite

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 hiring a (Contract) Human Factors Study Lead- Combination Products to join our team.

Responsibilities:

• Lead 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.
• Support the human factors analysis of new and existing medical products 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
• Conduct data collection, analysis, and documentation to support regulatory
• Lead the execution of human factors consulting projects for multi-national and start-up companies. Compliance with regulatory agencies, especially FDA is mandatory.
• Design, development, implementation, moderation, data analysis, and report writing of human factors activities; including formative and validation usability studies.
• 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.
• 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 (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.

To learn more about our company, please visit our website: Life Science Solutions | Kymanox

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.