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
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
