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Project Manager
Ref No.: 18-04144
Location: Raynham, Massachusetts
Start Date: 04/13/2018
OVERALL RESPONSIBILITIES
The Project Manager will be responsible for all project management aspects of the Spine EU MDR program and specialize in product development, processes and metrics reporting. You will be leading the cross-functional project team through completion of all Client Synthes Spine Technical Documents to meet EU MDR requirements with collaboration of US and Swiss team members. Reporting of all Technical Document deliverables, tracking of Tech File completion rates budget and resourcing to Spine Platform Lead, Spine Leadership Team and Global Clientpedics MDR team is required.

In this exciting role, you will:

·Collaborate with stakeholders to develop and maintain project plans.
·Create, monitor and analyze project risks and identify mitigation strategies.
·Be responsible for all project communications to all cross-functional project stakeholders and communications include: project websites, meeting minutes, status reports, presentations, and any other detailed project information needed.
·Report metrics of completion status, resourcing, budgeting to Spine platform manager, Spine Leadership Team and to Global Clientpedics MDR Director
·Communicate with and be main point of contact with all internal stakeholders (Supply Chain, Marketing, CER team, Clinical, Manufacturing, Finance, Purchasing, Sterilization, Packaging, Regulatory, Quality, etc.) regarding project activities.
·Work with project team to identify and address critical path or road block issues.
·Define and manage key project constraints such as scope, schedule, budget, resources and risks.
·Ensure project plans and deliverables are compliant with appropriate design control procedures and any other applicable procedures and/or regulations.
·Be the liaison with stakeholder managers as needed to ensure project goals are achieved.
·Know and follow all laws and policies that apply to the job and maintain the highest levels of professionalism, ethics and compliance at all times.
·Track the progress of technical files and report the status during the Global Clientpedics Interdependency Meeting, Spine Leadership Team meetings and weekly Spine Platform meeting
·Work collaboratively with all the cross functional team and provide necessary support
·Provide summary of offshore and onsite contract budget spent monthly/ quarterly/ yearly
·Predicts, plans and executes budgeting and resourcing for future MDR work.
·Drives effective communication across the functions of R&D, Quality, Regulatory, Operations and Marketing to ensure successful collaboration and execution
·To ensure timely execution of project objectives, the candidate must have strong problem-solving skills and initiative, and the ability to provide efficient escalation of issues to the appropriate accountable party
·Responsible for overall execution of activities to update Technical Files to MDR compliance, including establishing key performance indicators, performance metrics and risk mitigation activities.






Qualifications
  • A minimum of a Bachelor's degree in Business, Engineering or related field is required.
  • A minimum 5 years' relevant experience is also required.
  • Experience managing projects is required.
  • Experience in medical device product development, from early development through launch is highly preferred.
  • PMP Certification is preferred.
  • Experience in the medical device industry is preferred. Spine preferably.
  • Proficiency in the following project management knowledge areas: effective collaboration, integration, scope, time, cost, quality, resourcing, communication, risk and procurement are highly preferred.
  • Experience managing geographically dispersed teams is preferred.
  • Developed leadership capabilities and negotiation skills, as well as developed communication skills to effectively assimilate and communicate complex information from multiple sources is required.
  • Ability to recognize and lead the resolution of project issues and road blocks is also required.
  • Excellent verbal, written and presentation skills are required.
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Outlook) is required.
  • Familiar utilizing project lifecycle management (PLM) software is preferred.
  • Experience managing large amounts of data and consolidating information to meaningful reporting to management teams is preferred
  • Knowledge of medical device regulations (MDD and MDR) and quality requirements preferred.