Senior R&D Mechanical Engineer

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Job Function:
R&D Product Development

Job Sub Function:
R&D Mechanical Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Boston, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Senior R&D Mechanical Engineer to join our Orthopaedics team.

This is a hybrid position that will be based in Boston, MA.

Key Responsibilities:


* Design and develop technology and supporting instruments for robotic applications


* Use technical curiosity for the engineering and development of robotics systems and medical devices


* Lead internal and external partnership R&D projects


* Operate with latitude contributing to or leading multi-disciplined core teams


* Create and monitor technical aspects of multiple workstreams and projects


* Understand and utilize design controls for all technical aspects of product development including the development of design inputs and outputs and the verification and validation of medical devices including software


* Analyze and evaluate new technologies and develop improvements to existing products


* Demonstrate strong proficiency in the application of design controls and development processes


* Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and ISO 14971.


* Support design transfer and product launch activities, including complaint investigations.


* Investigate and document nonconformances, deviations, and test failures; drive root cause analysis and corrective actions.


* Interface with Regulatory, Quality, and Manufacturing teams to support audits and inspections.


* Support post-market surveillance activities by providing technical analysis, product documentation, and investigation support.


* Assist with handling obsolescence and technology upgrades.


* Communicate business-related issues or opportunities to the next management level.


* Follow all Company guidelines related to Health, Safety, and Environmental practices, as applicable.


* Train, develop, and evaluate more junior engineers, contractors, engine...