- Innovenn, Inc.
- Madison, Wi(Hybrid)
- Start date
- Mar 23, 2023
- Administration, Quality, General
- Required Education
- Bachelors Degree
- Position Type
- Full time
This position provides scientific and technical support to assigned billable and non-billable projects. This position conducts research, collects and analyzes data in various areas of corporate interest including but not limited to business development, medical device and drug development, regulatory guidance, human factors testing, etc. This position also supports documentation processes associated with Quality Management and training procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Assists with the development, validation and documentation of new products and expansion of existing products following industry best practices and design controls in support of providing best in class services.
Drafts, edits, and/or reviews project documents following design applicable procedures, regulations, standards, and guidance’s as needed, e.g., plans, test procedures, protocols, reports, submission summaries.
Conducts literature research in various areas that may be scientific, market, or client related to acquire the most current and accurate information on the assigned topic.
Collects and analyzes data as instructed to achieve desired outcome.
Prepares finalized materials, i.e., slide decks, charts, for presentation to internal/external teams. Attends project meetings to take notes and capture information and action items as requested to ensure accurate documentation.
Assists in the execution of project plans to satisfy required actions, milestones and deadlines.
Organizes and maintains project related quality system documentation and training files to ensure accurate historical data and SOP adherence.
Collaborates with various team members as appropriate to deliver quality outcomes for assigned projects supporting both internal and external needs.
Specifically for Human Factors Trials:
Ensures that the appropriate facility room is set up in a timely and accurate manner per the specified protocol.
Documents receipt and storage of study-related materials following standard operating procedures.
Transports all study supplies to the assigned location ensuring there are complete and adequate amounts.
Ensures accurate set-up of any video equipment and resolves any technical issues before, during or after testing.
Monitors and records the environmental measurements for each training and testing session.
Documents start and stop times during study, obtains signatures (participants and observers), and other testing related documentation as needed, e.g., video capture, environmental documentation.
Dispenses participant compensation, if any, at the end of the testing session
Ensures and obtains documentation on calibration of all equipment as per company SOPs.
OTHER DUTIES AND RESPONSIBILITIES:
Provides quality control/assurance document editing for grammar, consistency and adherence to design format as assigned.
Maintains and increases job knowledge by studying the state-of-the-art, ongoing research in the field, etc.; participate in educational opportunities; reads professional publications; maintains personal networks; participates in professional organizations.
Adheres to stated policies and procedures relating to health and safety, and quality management.
Note that 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:
Associate or Bachelor’s degree in health-related discipline. Minimum of one (1) year professional business experience required. Advanced proficiency using Microsoft Office Suite including Power Point, Word and Excel required.
Demonstrated experience as a self-starter and a fast learner; must work efficiently, both independently and within a team; must have exceptional organizational abilities, very good problem-solving skills and attention to detail. Excellent written and verbal communication skills are required and must be able to write clear reports, papers, proposals, etc.
COMPANY BENEFITS AND PERKS:
- Great Corporate Culture and Team
- Competitive Compensation
- Ten (10) Paid Holidays
- 3 Weeks/Year PTO Accrual Rate at Start
- Medical (both HMO and PPO Options), Dental and Vision - Employer paid 70%
- Employer paid Long-term Disability, Short-term Disability, AD&D/Life Insurance - $10,000
- Employee Assistance Program (EAP)
Founded in 2013, Innovenn is a 100% women-owned small business with an over 50% female workforce. Innovenn, Inc., helps client’s develop patient centered leading edge, AI-enhanced, medical device software (SaMD). At the intersection of engineering and data science, Innovenn and our collaborators take deep learning into the real world to improve human health. We leverage the latest advances in machine learning, artificial intelligence, and strong engineering foundations to guide development of software that is regulated as a medical device (SaMD). Our team has expertise in program and technical project management, quality management, product risk analysis and mitigation, human factors testing/user insights, and regulatory strategy/submission support that enables our clients to launch disruptive health solutions. In everything, our goal is to improve health outcomes by helping clients envision innovative ways to meet patient needs.
6410 Enterprise Lane
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