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Sr. Mechanical Engineer
Ref No.: 18-00915
Location: Raynham, Massachusetts
Start Date: 07/09/2018
The MDR Registration Sr. Mechanical Engineer is a critical position responsible for execution of Product Registration Activities
• The Sr. Mech Engineer will prepare execution strategies and project plans for the implementation of the MDR.
• Coordinate the alignment and execution of all activities related building the new Technical Documentation and obtaining CE marking in compliance with EU MDR.
• Proactively coordinate cross-functional deliverables from Regulatory, Medical, Clinical, R&D, Restricted Substances, Biocompatibility, PMS and any other functions as needed
• Maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
• Develop plans using goals and objectives of the project, appropriate related procedures, applicable historical information, and other necessary resources to align projects.
• Ensure project plan and schedule are created and maintained. Ensure all interdependencies are captured and accounted for in the overall schedule and resource model.
• Dynamic problem solver able to anticipate potential problems and create solutions.
• Measure performance and progress of all assigned projects using appropriate tools and techniques. Manage and control changes to the project scope, project schedule, project resources, and project costs to keep the project plan accurate, updated, and reflective of authorized scope, budget and schedule
Key Words " to search profile:
Medical Devices product, technical file, planning and execution of Product Registration Activities, cross-functional deliverables, continuous process improvement, problem solving skills, etc.
Candidate should have MDR Registration, Medical Domain exp.
Required Skills:
• A minimum of a Bachelor s degree is required.
• A minimum of 8 years of related business experience is required
• Must have experience in Medical Device Organization.
• Ability to work independently, manage complexity and take ownership for deliverables is required.
Desired Skills:
• A degree in a Business or Engineering/Scientific discipline is preferred
• Experience within the following functions - Engineering, Operations, Regulatory or Research & Development is preferred.
•Experience of managing Projects with team members in several different locations is preferred
• Intermediate computer software skills, i.e. Microsoft Office is required
• Strong presentation skills - Able to communicate clearly and concisely across all levels of the company is preferred.