Project Manager (Product Sustainment Department)

Ultradent Products, Inc. • Salt Lake City, UT

25d • Onsite

About The Position

Ultradent, the global name in oral health is seeking a Project Manager to join Ultradent's Product Sustainment team. The Project Manager is a fundamental component in support of business growth, increasing gross margin and net revenue both domestic and globally. The Product Sustainment Project Manager is responsible for overseeing changes to existing products and processes. They are also responsible to plan projects to meet timeline, budget, and quality requirements, as well as represent the interests of all disciplines within the organization while implementing changes to products that are currently on the market. The Project Manager is also expected to encourage safe practices and enforce safety policies, in addition to: Developing and monitoring project risk management plans, resolving any issues that may arise during the project life cycle, interpreting situations/ issues into compliant paths with regards to FDA, ISO, and Oratech standards. Oversee updates to design history files (DHF) with post-market change control deliverables. Execution of project meetings, ensuring project deliverables are well understood, and actions are agreed upon, communicated, and followed up. Stand as 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. 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 device, 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.
• 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.
• Ability to use quantitative skills as demonstrated from past work experience.
• Ability to effectively use various computer software including Microsoft Office Suite (Word, Excel, Visio, Power Point), Smartsheet, and Oracle ERP system (including Agile PLM).
• Ability to mediate conflict between parties to obtain buy-in on a single path forward.

Nice To Haves

• PMI PMP Certification

Responsibilities

• Overseeing changes to existing products and processes.
• Planning projects to meet timeline, budget, and quality requirements.
• Representing the interests of all disciplines within the organization while implementing changes to products that are currently on the market.
• Encouraging safe practices and enforcing safety policies.
• Developing and monitoring project risk management plans.
• Resolving any issues that may arise during the project life cycle.
• Interpreting situations/ issues into compliant paths with regards to FDA, ISO, and Oratech standards.
• Overseeing updates to design history files (DHF) with post-market change control deliverables.
• Executing project meetings, ensuring project deliverables are well understood, and actions are agreed upon, communicated, and followed up.
• Serving as the first point of call for new projects, status reports and guidance.
• Providing updates as necessary to all project stakeholders.
• Monitoring components of activity to ensure project deliverables are met within scope, resource, time, cost, and quality.
• Coordinating with Business Unit and Brand Marketing teams over launch formats/volumes/timings to agree upon achievable launch plans.
• Creating project and quality system documentation for new products/processes and changes to existing products/processes.

Benefits

• Medical/Dental & Other Insurances (eligible the first of month after 60 days)
• Health Savings Account with employer contribution
• 401K Plan with employer matching contribution
• Employee access to discounted Ultradent products
• Excellent Paid Time Off (PTO) and Medical Time Off (MTO) account to support medical and military events
• Five days paid between Christmas and New Years
• Education Assistance
• Onsite Fitness Center

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level