Project Manager - Product Sustainment

About the role

The Project Manager will play a crucial role in supporting Ultradent's business growth, enhancing gross margin, and net revenue both domestically and internationally. Reporting to the Product Sustainment Team Leader, this position oversees changes to existing products and processes, plans projects to meet timelines, budgets, and quality requirements, and represents the interests of all organizational disciplines.

Responsibilities

• Oversee updates to design history files (DHF) with post-market change control deliverables.
• Execute project meetings, ensuring project deliverables are well understood, and actions are agreed upon, communicated, and followed up.
• Stand as the first point of call for new projects, status reports, and guidance.
• Provide updates as necessary to all project stakeholders, monitoring components of activity to ensure project deliverables are met within scope, resource, time, cost, and quality.
• Cook 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 is ideal.
• A strong understanding of regulatory guidance relevant to medical devices, specifically FDA’s CFR820.30 and ISO 13485:2016 is ideal.
• 1-3 years of experience leading cross-functional teams as a project manager, preferably in bringing new products to commercialization successfully is preferred.
• PMI PMP Certification preferred.

Qualifications

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

Skills

• Project Management
• Regulatory Compliance
• Team Leadership
• Communication
• Software Proficiency
• Conflict Resolution

Benefits

• Equal Opportunity Employer
• Global Workplace Culture
• Core Values: Integrity, Care, Quality, Innovation, Hard Work
• VEVRAA Federal Contractor
• PWDNET Contact Information