Project Manager

About the role

Ultradent is seeking a Project Manager to join the growing R&D Product Sustainment team. This role is a fundamental contributor to business growth, driving increased gross margin and net revenue both domestically and globally. The Project Manager oversees changes to existing products and processes, plans projects to meet timeline, budget, and quality requirements, and represents the interests of all disciplines within the organization while implementing changes to products currently on the market. The role also encourages safe practices and enforces safety policies.

Responsibilities

• Develop and monitor project risk management plans, resolving issues that may arise during the project life cycle.
• Interpret situations/issues into compliant paths with regards to FDA, ISO, and Ultradent standards.
• Oversee updates to design history files (DHF) with post-market change control deliverables.
• Execute project meetings, ensuring project deliverables are well understood, actions are agreed upon, communicated, and followed up.
• Serve as the first point of call for new projects, status reports, and guidance.
• Provide updates to all project stakeholders, monitoring components of activity to ensure project deliverables are met within scope, resource, time, cost, and quality.
• Coordinate with Business Unit and Brand Marketing teams over launch formats/volumes/timings to agree upon achievable launch plans.
• Create project and quality system documentation for new products/processes and changes to existing products/processes.

Requirements

• Bachelor’s Degree or a combination of education and 1-3 years of experience working with medical devices sufficient to perform essential duties.
• Strong understanding of regulatory guidance relevant to medical devices, specifically FDA’s CFR820.30 and ISO 13485:2016.
• 1-3 years of experience leading cross-functional teams as a project manager, preferably in bringing new products to commercialization successfully.
• PMI PMP Certification preferred.

Skills

• Ability to effectively manage projects under low levels of supervision.
• Excellent communication skills (oral and written), with the ability to communicate complex information to various departments throughout the company.
• Ability to use quantitative analysis as demonstrated from past work experience.
• Proficiency in various computer software including Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Smartsheet, and Oracle ERP system (including Agile PLM).
• Ability to mediate conflict between parties to obtain buy-in on a single path forward.