President/Chief Executive Officer
This position leads the design, development and conduct of human factors testing for a variety of medical device and combination products. Interfaces with clients, study participants and team members. Serves as the single point of test control and is responsible for the overall conduct of testing, and creation and submission of final reports. Participates in corporate business development initiatives as appropriate to expand client base to meet corporate goals.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Leads the day-to-day operations of the human factors lab and its business strategies in support of company initiatives and financial goals.
Provides human factors content and guidance to regulatory filing strategy, documentation (e.g., pre-submission, 510k, NDA, etc.) and communication, including participation at regulatory agency meetings as required to assist in clients’ desired product approval goals.
Expands the human factors client base by proactively building repour with and seeking repeat business from existing clients and through defined business development efforts as agreed upon with the CEO, to increase revenue and broaden business base.
Oversees and participates in entire user-based product risk analysis process including development and/or review of documentation to meet all appropriate SOPs and regulatory guidance.
Oversees and participates in writing compliant human factors testing protocols and reports to meet and/or exceed client expectation and meet all FDA reporting guidelines.
Oversees all recruitment services and recruitment team to secure qualified participants in a study in accordance with the study protocol and applicable agency participant guidelines.
Approves study protocols, reports and any amendments to validate accurate interpretation need, appropriate study design and execution per client and regulatory agency requirements.
Provides QA team member(s) with a copy of the protocol and ensures timely and concise communications with QA during each study to ensure proper understanding and study conduct.
Ensures protocols, amendments and all other study materials are available to study personnel and all personnel are trained before performing any project responsibilities to ensure highest quality performance by properly trained staff.
Oversees compliance by study personnel and participants to ensure all procedures specified in a protocol and applicable SOPs are followed and any deviations from the plan on quality and integrity of the study are remedied.
Provides an overview to study participants ensuring understanding and compliance to the test protocol and procedures is maintained during all testing sessions.
Oversees the documentation of all raw data generated during a study to ensure all data is fully documented and recorded.
Oversees and/or leads root cause analysis process and documentation to facilitate effective product risk analysis reporting and product update recommendations to assist in clients’ products meeting regulatory human factors development guidance requirements.
Ensures that computerized systems used in a study have been validated to provide error free support.
Ensures that all protocols, raw data, and final reports are archived timely and appropriately to ensure company policies and procedures are followed.
Defines practices for collection and analysis of user behavior data through a variety of methods, such as formative evaluations, interviews, observations, usability studies, surveys A/B testing or task analysis to ensure highest quality studies are conducted.
OTHER DUTIES AND RESPONSIBILITIES:
Reviews all requests for HF proposals and in collaboration with other team members develops an appropriate approach to provide needed services. Helps clients to understand their need and ensures accuracy of Innovenn and its affiliates’ assumptions and client understanding of proposal submission. Ensures appropriate resourcing and pricing to ensure highest opportunity for contract award and project profitability.
Overseas the development, review and editing of non human factors focused protocols, summaries, test reports and design control documentation to ensure accurate deliverables.
Ensures completion of critical tasks such as developing user needs and requirements documentation and presents research results to clients to provide complete and accurate data in detail to meet all agency guidance.
Maintains and increases job knowledge by studying the state-of-the-art, ongoing research in the field, etc.; participates in educational opportunities; reads professional publications; maintains personal networks; participates in professional organizations.
Note: this position description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities that are required in the performance of this job. Duties, responsibilities, and activities may change at any time with or without notice.
MINIMUM EDUCATION, SKILLS AND EXPERIENCE REQUIRED:
MS in Human Factors, Psychology or life science field with 10 years applicable work experience and expertise in human factors testing. Advanced knowledge and implementation of the latest FDA guidance on medical device and combination product usability and how to interpret and apply the guidance. Demonstrated experience with conducting human research, Good Clinical Practices, applicable FDA regulations, Good Documentation Practices, and data collection methods. Demonstrated experience in successful regulatory submissions for medical device and combination products.
A strong analytical and statistical background to include quantitative and qualitative data analysis, project and program management and the ability to apply them to a wide variety of strategic and tactical programs. Ability to improvise as needed to keep research sessions flowing and to discover unexpected insights.
Demonstrated ability to collaborate and lead in a flexible, detail-oriented, fast-paced team environment in a growing organization. Strong communications to interact positively and in a professional manner, excellent critical thinking with problem-solving skills and an ability to work cooperatively in a team. Flexibility in responding to changing demands, timelines, and priorities is also required.