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Reference # : 18-36583 Title : MDR - Project Manager
Location : North Haven, CT
Experience Level : Start Date / End Date : 07/23/2018 / 07/26/2019  
Company: Artech Information Systems
Job Title: MDR - Project Manager
Location: North Haven, CT
Job ID: 18-36583
Duration: 12+ months
  • This position will be responsible for project management with regulatory consequences and significant cross functional support within the Surgical Innovation (SI) business unit.
  • The Project Manager will provide support and leadership to a cross-functional team including subject matter experts (SME), and requires the ability to drive tactical activities while communicating effectively with a large group of stakeholders.
  • The Project Manager is accountable for alignment with the corporate project team and work stream strategies to drive harmonization across the BU / MITG / Healthcare where appropriate. The Project Manager is responsible for ensuring team commitments (scope, schedule and budget) are met; and for communicating program status to senior leadership on a regular basis.
Education/ experience:
  • 5 years with Bachelor’s; or 2 years with Master’s in Regulatory Affairs, or a function familiar with technical files and medical device product development process
  • BS/BA degree or equivalent degree in Business Management, Engineering, or other related field of study.
Preferred Skills/ Qualifications:
  • Lean or Green Belt certified a plus, with solid PM implementation experience required.
  • A minimum of 5 years of QARA and/or plant manufacturing or engineering experience, which includes a minimum of 5 years of demonstrated process improvement and project management success.
  • Knowledge of current European medical device directives (MDD/AIMDD) and CE mark process
  • Ability to work independently or collaboratively to determine and develop approaches to solutions
  • Experience driving initiative and change management across a BU
  • Excellent verbal, written communication and presentation skills;
  • Experience delivering presentations at all levels in an organization
  • Experience influencing stakeholders at multiple levels in an organization
  • Experience with MS Project, Excel, PowerPoint, Word, SharePoint
  • Demonstrated ability to work successfully in complex business and project areas, leveraging interpersonal skills and technical skills to optimize results
  • Broad business knowledge and ability to link customer needs with business processes
  • Strong analytical problem-solving skills.
  • Ability to support multiple projects and balance priorities.
  • Ability to work independently and with all levels of managers, associates, and clients
  • Strong coaching, facilitation and organizational skills.
  • Excellent oral/written communication and platform skills.
Rajiv Maruthi