Ultradent, the global name in oral health, is seeking a Project Manager to join Ultradent's growing R&D Product Sustainment team.
The Project Manager is a fundamental contributor to business growth, helping drive increased gross margin and net revenue both domestically and globally. If you have a background in project management within manufacturing, R&D product development or sustainment, life sciences, medical device, regulatory compliance, or other regulated industries—and thrive in a cross-functional environment—we encourage you to apply.
The R&D 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
WHAT YOU’LL NEED TO SUCCEED:
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
Strong understanding of regulatory guidance relevant to medical device, 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
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 use quantitative 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
Ultradent is an Equal Opportunity Employer. We are a global culture where differences and perspectives are sought after, welcomed, and embraced. We consider all qualified applicants fairly, based on their experience, skills, and potential to contribute to our team. Our core values – Integrity, care, quality, innovation, and hard work- guide us daily. These values, when balanced, shape our workplace culture and ensure that we remain focused on our vision while maintaining a professional and inclusive environment.
VEVRAA Federal Contractor: For more information please contact us at [email protected]
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Skills Required
- Bachelor's degree or equivalent experience working with medical devices (1-3 years)
- Understanding of FDA CFR820.30 and ISO 13485:2016 regulatory guidance
- 1-3 years leading cross-functional teams as a project manager, preferably with product commercialization experience
- PMI PMP certification
- Proficiency with Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Smartsheet, and Oracle ERP (including Agile PLM)
- Excellent oral and written communication skills
- Ability to manage projects with low levels of supervision
- Ability to use quantitative methods as demonstrated in past work experience
- Ability to mediate conflict and obtain cross-functional buy-in
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
