NEW JOB OPENING
PRINCIPAL R&D PROJECT ENGINEER (MEDICAL ROBOTICS)
IN NEWTON, MA, USA!

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Per call with the manager 11/28:
• The candidate will be working with the design readiness team which is the stage between R&D and manufacturing.
• Candidates are required to have product release experience in a regulated quality environment (medical devices, aerospace, etc.). Candidates with just research/academia experience are not qualified; must also have the product release experience.
• Candidates must be comfortable with software and firmware specifications and requirements writing for the software development team, but they will not be doing any of the software development themselves.
• Maximum of 45-minute commute to Newton, MA as this is a primarily in-person work opportunity.

Company Background:
The Company's Endovascular Robotics division, is a global technology leader in robotic assisted vascular interventions. The company's proprietary system is the first FDA-cleared medical device to bring robotic-assisted precision to neurovascular, percutaneous coronary and peripheral interventions. They are advancing the field of interventional medicine with robotics through improvements to procedural
control, precision, and workflow.

Position Summary:
• The Principal R&D Engineer will contribute to new product development by contributing to the development, testing, and documentation through variety of engineering projects, process improvements, and technical project management activities.
• This role will be an important contributor to realizing the next generation of interventional robotic platform.
• This is a collaborative opportunity where you will work cross-functionally with R&D, Quality Assurance, Quality Control, Manufacturing, and external vendors.
• This role is suited for an experienced R&D engineer with experience in developing complex medical devices and design transfer with broad knowledge of electromechanical, software, verification, and transfer to manufacturing within a regulated quality system.

Key Responsibilities:
• Being a key member working on design readiness of the robotic system
• Support development of assembly and test processes
• Support identification of, creating specification for, and development of the necessary characterization and in-line test and build fixtures
• Support development and maintenance of the BOM and DMR
• Support the creation of DHF
• Author relevant documents such as test protocols, test reports, analyses, and system documentations
• Support a variety of technical and process improvement projects of different sizes and disciplines
• Help with the vendor communications and procurements
• Manage and communicate assigned projects in collaboration with cross-functional teams

Qualifications:
• 10+ years electromechanical R&D engineering experience, at least 7 years in medical device required
• Bachelor’s degree in Mechanical/Robotics Engineering or a close field is required
• Experience in managing engineering projects required
• Must have previous experience launching products
• Must have in-depth knowledge of design verification of complex medical devices
• Deep knowledge and working experience of medical device design control is required
• In-depth knowledge and experience in transferring design to manufacturing is required
• Demonstrated CAD (Solidworks) proficiency required
• Familiarity with firmware and software within electromechanical systems is highly desired
• Experience in off-the shelf component selection for regulated industries highly desired
• Experience with statistical tools and software such as Matlab and Minitab is desired
• Able to execute assigned projects and duties with minimal supervision
• Proficiency in using MS Office is required