MDR Operations Project Manager - Orthopaedics

This role is accountable for providing Project Management expertise to the Medical Device regulation (MDR) Supply Operations team and will be responsible for creating, managing and executing plans to ensure S&N's products are implemented and released under MDR, in-line with agreed schedule for the given franchise.

The job holder will prepare detailed project plans, work breakdown structures, risk/issue registers and identify dependencies between activities within a global cross-functional programme. In addition the role will involve working across a number of MDR workstreams and operational business teams to track the progress of project deliverables, taking account of franchise or product specific requirements.

The identification and management of the key deliverables of a group of products will be under the remit of this role. The role will report the progress of preparing product for MDR implementation and release to the MDR Supply Operations Director, MDR Program Director and MDR steering group as appropriate.

The job holder is also expected to represent the selected franchise and communicate MDR related schedules, deliverables and progress through defined governance procedures.

A key aspect of the role is the Implementation of key project management disciplines and applying industry standard methodologies in-line with medical device regulations.

Responsibilities:

• Define the detailed scope of work, objectives and success criteria for a range of products in collaboration with MDR Supply Operations Director, MDR work stream leads and key business stakeholders.
• Create detailed work plans which identify, group and sequence the activities needed to successfully complete the project for each product group including major milestones, critical path and dependencies.
• Execute the projects according to the project plan ensuring this is aligned with the franchise downstream plan and MDR regulatory deadlines
• Develop a resource plan for project completion that effectively allocates the resources to the activities on the plan
• Chair regular project progress review meetings with project team and promote team working to facilitate the overall success of the MDR Programme
• Utilize project dashboards/scorecards to present an overall view on the project for management and key stakeholders, highlighting major risks and escalating issues as appropriate to facilitate decision making
• Represent the selected franchise within the MDR Programme and work closely with key business stakeholders to communicate progress and ensure business requirements are met
• Ensure Global And EU supply continuity through the transition from MDD to MDR whilst minimising exposure to raw materials write off and finished goods inventory stock builds
• Identify and actively manage dependancies between MDR and Business as usual projects

Location: Memphis TN, Andover MA Mansfield MA OR Austin TX

Education: Bachelors Degree required

Licenses/ Certifications: Project methodology qualification preferred (eg PMP, PMI)

Experience:

• 5 -6 years of project management experience
• Medical device manufacturing experience preferred
• Proven experience of working in a project environment on multiple projects with interdependencies and shared resources.
• Ability to work effectively with a range of business stakeholders from senior management to team members completing set tasks.
• Ability to present complex plans to senior stakeholders so high priority issues / roadblocks are clear
• Managing regulatory driven projects a benefit

Travel Requirements: Estimated 10-15% domestic and international

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.