Project Manager, Medical Device Development
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Job Location:
Madison, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Position Summary
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.
Essential Duties and Responsibilities
Project Planning & Cross-Functional Coordination
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.
Medical Device Development Execution
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.
Client Leadership & Vendor Management
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.
Technical Problem Solving & Documentation
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.
Quality Safety & Compliance
Adhere to Innovenn policies and procedures relating to health and safety and quality management.
Other Duties and Responsibilities
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.
Minimum Education Skills and Experience Required
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.
Key Competencies
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.
How to Apply
Please submit a resume and brief cover letter outlining your relevant medical device development and project management experience.
Required Experience:
IC
Key Skills
- Business Development
- Project Management
- Process Management
- Product Management
- Autocad
- Project Management Software
- Microsoft Project
- Customer relationship management
- Budgeting
- Product Development
- Project Implementation
- Google Suite
