Principal Mechanical Engineer - Motion Systems - Robotics & Automation

Position: Principal Mechanical Design Engineer - Project Lead Robotics/Robotics Design

Location: Greater Boston, MA.

Industry: Medical Technology / Medical Device

Salary: Commensurate with experience

Relocation Assistance Available.

Summary:

The Principal Mechanical Engineer will guide the successful completion of major programs and may function in a project leadership role. You will apply technical expertise toward developing world-class medical systems for image-guided surgery. You will develop technical solutions to complex problems that require the use of ingenuity and creativity. You will work with cross-functional teams on the design phase, and verification and validation phase of key projects.

Duties and Responsibilities:

• Technical Leadership role in an R&D product development environment to develop robotic guided imaging products. Serves as a technical expert in a cross-functional team developing mechanical designs (including design review facilitation).
• Responsible for all development phases: writing requirements, architecture documents, design implementation, writing test plans, execute tests and write verification reports.
• Responsible for mechanical designs that meet both internal and external customer requirements and are optimized for production, reliability, and cost.
• Perform design analysis and risk analyses, and coordinate system-level testing and validation efforts.
• Interface with outside vendors as needed to communicate design requirements and databases to ensure the accuracy of parts and subsystem manufacturing by vendors.
• Leads troubleshooting and problem-solving efforts related to the development projects. Supports decisions through engineering and analysis data.
• Participates in the evaluation of new technology, new products, new materials, and their impact on the business.
• Implements and maintains the project plans for new technology programs.
• Assist with activities relating to design, testing and evaluation of system elements.
• Mentors and provides technical guidance as required.
• Ensures appropriate documentation is maintained and completed for new technology programs, ensuring that information is transferred to product line-specific areas during the commercialization phase.
• Give direction to engineers and drafters, clearly communicate their roles and tasks. Finds and evaluates new ideas and new technologies.
• Works with product areas to outline testing of new products and conducts or coordinates product evaluation.

Education and Experience:

• Bachelor’s Degree in Mechanical Engineering, or closely related degree.
• Master’s Degree, strongly desired.
• Minimum of 7 to 10 of experience in medical devices, mechanical engineering, or other regulated industries.
• Experience in robotic design including belt drives, ball screws, stepper motors, and DC servo motors.
• Experience with system dynamics modeling, control systems design, and analysis of motion systems utilizing MATLAB/Simulink a plus.
• Experience with x-ray imaging systems a plus.
• Solid working knowledge of regulatory requirements for medical product development, including knowledge of federal and international regulations, such as FDA QSR, IEC 60601, ISO: 13485, 14971, 62304, and 13485, Medical Device Directive or other regulating agencies.
• Understanding of medical device’s development methodologies and medical device’s lifecycle, or other heavily regulated device’s lifecycle.
• Proficiency with Microsoft Outlook, Excel, and project scheduling such as Microsoft Project is desirable.

• Interpersonal, written communications, time management, and organizational skills.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health, and safety-related site rules, policies, or governmental regulations.
• Travel requirement: Less than 10%