Job Description

• Leads the project team through all phases of Design Control to achieve project goals within established scope, time, and quality constraints.
• Creates or directs preparation of all documents including, but not limited to protocols, reports, traceability matrices, SDS documents and labeling required for the Design History Files of medical devices.
• Determines and tracks resources such as time, capital, labor, and equipment required to complete projects.
• May assist executive management in the preparation of project proposals including scope, schedule, budget, and deliverables.
• Manages progress of projects to ensure alignment with business strategy, sound application of engineering principles, and adherence to Prismatik’s Quality Manual and applicable industry standards.
• Manages and implements appropriate action with respect to timelines, milestones, planning, and resource allocations.
• Identifies elements impacting project, such as personnel issues and project gaps, bottlenecks, and risks. Develops solutions and/or implements corrective actions to ease issues, eliminate delays, and mitigate risks using appropriate knowledge, skills, and techniques.
• Evaluates and analyzes final testing results. Provides manufacturing guidance.
• Communicates with project stakeholders, various departments, and applicable vendors to achieve design intent.
• Updates management regarding project strategy, progress, and alignment with executive direction.
• Creates and produces reports regarding projects for management and team members.
• Performs other related duties and projects as business needs require at direction of management.

• Bachelor’s degree in Engineering or scientific related discipline, preferred.
• Minimum five (5) years of experience in R&D performing higher value-added roles and functions.
• Minimum three (3) years of experience in project management; medical device industry experience, a plus.
• Demonstrated knowledge of International Organization for Standardization (ISO) and Food and Drug Administration (FDA) standards and requirements for medical devices.
• Certification in Project Management, a plus.