Project Manager, Medical Device Development

Innovenn, Inc.•Madison, WI

23h

About The Position

Innovenn is seeking a Project Manager, Medical Device Development to support the managerial, scientific, and technical execution of assigned projects. This role brings expertise in medical device development and the device approval process while providing strong project management support to cross-functional teams. Independent judgment is required to plan, prioritize, and organize a diversified workload in support of high-quality client outcomes.

Requirements

BA or BS degree in a 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.
Experience with the device approval process (e.g., 510(k) application).
Strong computer skills including Microsoft Office Suite and MS Project.
Demonstrated ability to interpret technical drawings, blueprints, specifications, illustrations, and written documents.
Self-starter and fast learner able to respond to changing priorities with minimal disruption.
Strong analytical, research, and problem-solving skills with attention to detail.
Ability to consistently meet deadlines and manage multiple projects across several collaborators.
Excellent written and verbal communication skills, including the ability to write clear reports, proposals, and communicate effectively with scientists, engineers, and customers.

Responsibilities

Serve as the intermediary between technical and business day-to-day operations of medical device development.
Organize project plans for complex projects that satisfy required milestones, deadlines, and deliverables.
Identify topics requiring further subject matter input (e.g., QMS, Regulatory, R&D, Manufacturing, Marketing) and facilitate efficient team discussions.
Prepare materials to support clear, effective project communication.
Coordinate development, validation, and documentation of new products and expansion of existing products, including defining requirements, timelines, and deliverables.
Interface with clients, vendors, subcontractors, and project team members to understand scope of work and support delivery of appropriate solutions.
Develop overall project timelines, budgets, and performance evaluation strategies, including verification and validation planning that integrates discovery, development, and testing activities.
Serve as client liaison and/or team leader, as assigned, providing support and direction to cross-functional project teams.
Facilitate on-site visits, team and client communications, and project budget adherence, including planned corrective actions as needed.
Select and manage key vendors to ensure design specifications, implementation, and quality control align with project goals, product specifications, and deadlines.
Propose algorithmic solutions and trade-off analyses to problems presented by vendors, technical team members, or customers.
Document project decisions and methodologies through flowcharts, layouts, diagrams, charts, and other materials.
Write project documents as needed, including plans, test procedures, protocols, and reports.
Support implementation plans that enable potential device application filing.
Adhere to Innovenn policies and procedures relating to health and safety and quality management.
Assist with business development activities, including defining project scope, timelines, and budgets for proposals and quotes.
Review project budgets for accuracy and sensibility.
Design, develop, and conduct human factors testing for a variety of products, interfacing with clients, participants, and team members while ensuring protocol compliance.
Maintain and increase job knowledge through ongoing research, educational opportunities, professional publications, networks, and organizations.