Janet Lowe Email & Phone Number

San Clemente, Ca, Us

I am recently retired and worked the past as Director, Medical Affairs. I lead a team of RN’s and Pharmacist in supporting new device and software development in addition to supporting all legacy products.

San Clemente, Ca, Us

Lead and develop a team of Device Development Specialists for products in development of our infusion pumps, safety software and consumable drug delivery systems. Manage workflow, coverage, schedules and daily activities of team members and coordinate workflow volume and metrics with management.Actively review product specifications, risk analyses, and data for 510(k) submission requirements. Plan, execute and report Human Factors testing on all products for use safety. Includes participation in all aspects of use error risk analysis development (UERA) and testing to validate mitigations identified in the UERA. Serving as the primary point of contact with manufacturing and software developers when issues arise which require medical evaluation, training, or problem-solving. Medical lead and decision-maker regarding product specific questions. Lead the clinical evaluation report preparation for new device CE registrations. Manage data collection & analysis of user input during the development process, with emphasis on early “concept phase” projects.

Hospira purchased by Pfizer and worked in product quality followed by device development. This included new and sustaining product. Company was sold to Pfizer and promoted to senior manager of new product development. Division was sold to ICU Medical and later promoted to Director, Medical Affairs. Responsible for all new product development, including Human Factors and submission preparation.

Lake Forest, Il, Us

•Manage, lead and develop a team of Device Development Specialists for Consumable projects under development in the R&D Organization. •Coordinate review of Consumable product specifications, risk analyses, and data for 510(k) submission requirements. •Coordination all aspects of use error risk analysis development (UERA). •Planning and execution of formative and summative human factors testing to validate mitigations identified in the UERA. •Manage Consumable Device Development Specialists which include development, coaching, and mentoring as well as manage the hiring and training of new staff•Coordinate activities of Consumables team within Global Medical Device Development•Oversee and ensure training and compliance of team members and ensure coordination and completion of scientific documents.•Review and approve protocols, usability test reports, use error risk analyses, and Labeling•Manage workflow, coverage, schedules and daily activities of team members and coordinate workflow volume and metrics with management, and identify trends.

Lake Forest, Il, Us

•Acted as Medical lead for consumable devices. Serve as clinical expert to engineering and provide medical support for device development by translating clinical uses and issues to engineering. •Support launch of new products by co-coordinating with local sales team site visits, conducted pre-implantation meetings, offer product insights or additional product knowledge, served as expert user of product for clinical and sales representatives•Medical liaison responsible for working with program managers and marketing to determine criteria for site selections, providing development team with clinical expectations and requirements. •Served as contact to ensure time lines are met, coordinate and provide product training for various functional areas, participate in the testing requirements to include work flow and user interface.•Interface with marketing managers for assigned products and provide medical and clinical input.•Serve as liaison between device development team and customer.•Facilitate product complaint process for quick issue resolution.•Mentor, coach and provide guidance for new medical staff members.

•Responsible for the development, coordination and execution of system and product training activities for the complaint management organization: included logging, tracking sample testing, investigation, analysis and closing of product complaints in a timely manner. •Responsible for all aspects of training: including product knowledge and systems training for new hires, planning and presentation of topics related to ongoing education, development of SOP’s and training modules, training of medical analysts integrating into the quality role.•Coached new analysts on all aspects of the job including but not limited to: common clinical practices, internal and external customer needs, and regulatory and compliance requirements. •Responsible for managing work priorities and complaint processing for the critical care, surgicare and infusion product lines.•Performed training of international sites on complaint processing and system operation. Trained manufacturing sites regarding product knowledge of the products they manufactured to improve quality process within the site. •Developed orientation program to meet defined departmental needs.•Implemented the transfer of serialized complaints from external to corporate headquarters. •Responsible for the evaluation of employees for evidence of mastery of content.•Acted as Subject Matter Expert regarding complaint processing and product knowledge for GCM and manufacturing facilities.

•Medical device and pharmaceutical sales representative covering Southwest Florida territory for non acute health care facilities. •Worked as district trainer: organized training needs for the five state district on specific devices and product lines, maintaining and updating skills competencies for district, district meeting planning and organizing.•Participated as national trainer for specialized product lines.•Drafted training tools utilized today for new hire training.•Achieved National All Star.•Consistent record of meeting and exceeding goals.

Abbott Park, Illinois, Us

•Medical device and pharmaceutical sales representative covering all acute care hospitals in Hawaii.•Turned underachieving territory around by building relations and securing contracts with annual growth of 16 %.•Secured extensive hospital contract worth millions over the term of the contract by piloting IV assessment tool for national account.•District trainer.

Honolulu, Hi, Us

Served as ICU charge nurse and preceptor for a large coronary intensive care unit. Managed staff and did direct patient care.Prepared statistical analysis for the cardiac procedures laboratory, utilizing regression analysis and exponential smoothing.Prepared marketing audit for the Queen’s Medical Center/Homeless Aloha Program.Active member of new product selection committee.

Master Of Business Administration - Mba, Health/Health Care Administration/Management And Marketing

Registered Nursing/Registered Nurse

Master Of Business Administration - Mba, Health/Health Care Administration/Management