Project Manager (Product Sustainment Department)
Ultradent the global name in oral health is seeking aProject Managerto join Ultradents Product Sustainment Project Manageris a fundamental component in support of business growth increasing gross margin and net revenue both domestic and globally. The Product SustainmentProject Manageris 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.
TheProject Manageris 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 YOULL NEED TO SUCCEED:
- Bachelors 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 FDAs 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
WHAT WERE 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
PWDNET
Required Experience:
IC
Project Manager (Product Sustainment Department)Ultradent the global name in oral health is seeking aProject Managerto join Ultradents Product Sustainment Project Manageris a fundamental component in support of business growth increasing gross margin and net revenue both domestic and globally. The P...
Project Manager (Product Sustainment Department)
Ultradent the global name in oral health is seeking aProject Managerto join Ultradents Product Sustainment Project Manageris a fundamental component in support of business growth increasing gross margin and net revenue both domestic and globally. The Product SustainmentProject Manageris 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.
TheProject Manageris 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 YOULL NEED TO SUCCEED:
- Bachelors 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 FDAs 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
WHAT WERE 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
PWDNET
Required Experience:
IC
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