This position supports the managerial, scientific, and technical aspects of assigned projects. In addition to providing expertise in medical device development and the device approval process, this position provides management support and techniques to assigned teams. Independent judgment is required to plan, prioritize and organize diversified workload.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Serves as the intermediary between the technical and business day-to-day operations of medical device development to organize a project plan for complex projects that satisfies milestones and deadlines with required actions. May be required to identify the topics/subjects (QMS, Regulatory, R&D, Manufacturing and Marketing) that may need further input from subject matter experts. Facilitates these conversations and prepares materials to ensure these communications are efficient and effective.
Coordinates development, validation and documentation of new products and expansion of existing products, including defining requirements, timelines, and deliverables. Interfaces with clients, vendors, sub-contractors, and other project team members to understand the scope of work and provide the best solution.
Develops overall project timelines, budgets, and performance evaluation strategies including verification and validation that integrate steps for discovery, development and testing of prognostic, diagnostic and predictive tools across disciplines to provide highest quality solutions to clients.
Serves as client liaison and/or team leader, as assigned, to provide support and direction to cross-functional project team including facilitating on-site visits, team and client communications as well as project budget adherence including planned corrective actions as needed.
Selects and manages key vendors to create the appropriate design specifications, execute implementation, and establish quality control of all product features suited to specific disease indications ensuring all client and project goals, product specifications and deadlines are met.
Proposes algorithmic solutions and trade-off analysis to problems presented by vendor, technical team members, customers, etc., including the entire process from problem definition to pertinent concepts and solutions to facilitate project outcomes and goals.
Demonstrates proposed solutions by developing documentation, flowcharts, layouts, diagrams, and charts, etc., documenting project decisions and methodologies.
Collaborates with technical/therapeutic area experts to deliver the most desired solutions for assigned projects to ensure delivery of quality outcomes.
Writes project documents as needed, e.g., plan documents, test procedures, protocols and reports.
Enables potential device application filing through implementation plans as appropriate.
Adheres to stated policies and procedures relating to health and safety, and quality management.
OTHER DUTIES AND RESPONSIBILITIES:
Assists with business development activities, e.g., defining project scope, timeline and budget for proposals and quotes. Reviews project budgets for accuracy and sensibility.
Designs, developments and conducts human factors testing for a variety of types of products. Interfaces with clients, user participants and team members. Provides an overview to user participants ensuring compliance to the test protocol and procedures is maintained during the testing sessions.
Maintains and increases job knowledge by studying the state-of-the-art, ongoing research in the field, etc.; participate in educational opportunities; read professional publications; maintain personal networks; participate in professional organizations.
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:
BA or BS degree in health related discipline. Minimum of five (5) years of professional scientific and/or biotechnology/medical device development project management experience. Experience with direct line management and experience with device approval process (e.g., 510K application).
Strong computer skills including the MS Office suite and MS Project. Demonstrated ability to interpret technical drawings, blueprints, specifications, illustrations and written documents
Demonstrated experience as a self-starter and a fast learner; must work efficiently responding to changing priorities with minimal disruption, able to work independently and within a team; must have excellent problem solving skills, analytical skills, research skills and attention to details. Must be able to consistently meet deadlines, manage projects across several collaborators and handle multiple projects simultaneously. Excellent written and verbal communication skills are required and must be able to write clear reports, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers.