Ultradent, the global name in oral health is seeking a Project Manager to join Ultradent's Product Development 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 Development Project Manager is responsible for overseeing new product development projects. They are also responsible for planning and executing project timeline, budget, and quality requirements, as well as represent the interests of all disciplines within the organization. They will take ownership and responsibility for the project from inception through the design control process and all deliverables required to meet regulatory requirements and manufacturing processes through completion and transfer for the launch of the new product to the market.
The Project Manager is also expected to encourage safe practices and enforce 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 creation and buildout or 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
WHAT YOU’LL NEED TO SUCCEED:
- Bachelor’s Degree or a combination of education and 3+ years of experience in successfully managing projects in any industry is ideal. Manufacturing and medical device preferred but not required.
- Strong understanding of regulatory guidance relevant to medical device, specifically FDA’s CFR820.30 and ISO 13485:2016
- 3+ years experience leading cross-functional teams as a project manager, preferably in bringing new products to commercialization successfully is also ideal.
- PMI PMP Certification preferred but not required.
WHAT WE’RE LOOKING FOR IN YOU:
- 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 adapt and solve problems 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
- Ability to learn processes and contribute to continuous improvement
Ultradent is an Equal Opportunity and Affirmative Action Employer. We are a global culture where differences are sought after, welcomed, and embraced. All qualified applicants will receive consideration for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
VEVRAA Federal Contractor: For more information please contact us at [email protected].
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What We Do
Ultradent Products, Inc., is a leading developer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s mission is to improve the level of dental health care and to make dental procedures more predictable and efficient. Consistent with its mission, Ultradent works to improve the quality of life and the health of individuals through financial and charitable programs.
Ultradent evolved from a dentist’s quest to create more effective dental products. Dr. Dan Fischer's desire to develop more advanced dental products led him to create products that would set future industry standards.
Today, Ultradent has subsidiaries in Germany, Italy, Brazil, Spain, Malaysia, China, and Japan, employing approximately 1,900 individuals and manufacturing and packaging more than 500 materials, devices, and instruments. While Ultradent has expanded into a worldwide company, the majority of its professional and skilled manufacturing positions have remained in the United States, providing jobs for a diverse community of Americans. Ultradent is committed to local production and is proud to be a USA manufacturer.
Ultradent’s products are used worldwide by dentists, group practices, dental and veterinary labs, government agencies, and universities. Ultradent has continued its development efforts, holding dozens of patents and trademarks on unique products, materials, devices, and application techniques
