Careers in MedTech

Job Title

Principal Mechanical Engineer

Company

Medtronic

Description

This position guides the successful completion of major programs and may function in a project leadership role.  Applies technical expertise toward developing world class medical systems for image guided surgery.  Develops technical solutions to complex problems that require use of ingenuity and creativity. Works with cross-functional teams on the design phase, and verification and validation phase of key projects.

The O-armTM system is an intraoperative 2D/3D imaging system that is designed to meet the workflow demands of the surgical environment. It can be used in variety of procedures including spine, cranial, and orthopedics.

To view more product details please view the link below:

https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/surgical-imaging-systems/o-arm.html

A Day in the Life

  • Technical Leadership role in an R&D product development environment to develop our robotic guided imaging products. Serves as a technical expert in cross-functional team developing mechanical designs (including design review facilitation).
  • 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.
  • Responsible for all development phases: writing requirements, architecture documents, design implementation, writing test plans, execute tests and write verification reports.
  • 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.
  • Adhere to Medtronic Standard Operating Procedures.
  • 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.
  • 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 commercialization phase.
  • Finds and evaluates new ideas and new technologies.
  • Works with product areas to outline testing of new products and conducts or coordinates product evaluation.
  • Assist with activities relating to design, testing and evaluation of system elements.
  • Give direction to engineers and drafters, clearly communicate their roles and tasks.
  • Comply with regulatory requirements, including company design control procedures
  • Ensure business’ quality policy/system is planned, understood, implemented and maintained in business.
  • Provides information to senior management
  • Serves as a representative as a prime technical contact and interacts with senior internal/external personnel on significant technical matters.
  • 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
  • All other duties as assigned.
  • Travel requirement: Less than 10%

Must Have: Minimum Requirements

  • Bachelors degree in a technically related flied required
  • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice to Have

  • Mechanical or equivalent 5+ years of experience in medical device mechanical engineering or other regulated industries required
  • Experience in Mechanical design of motion systems; familiarity with transmissions such as belt drives, ball screws, bearing selection, and motor selection including stepper motors and DC servo motors.
  • Experience with system dynamics modeling, servo-systems design and analysis of motion systems. Familiarity with Matlab/Simulink a plus.
  • Experience with x-ray imaging systems a plus
  • Experience with Solidworks simulation for static, dynamic, and thermal analyses
  • 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 is required.
  • Understanding of medical device’s development methodologies and medical device’s lifecycle, or other heavily regulated device’s lifecycle
  • Proficiency with Microsoft Office Programs:  Outlook, Excel, and project scheduling such as Microsoft Project is desirable.
  • Interpersonal, written communications, time management, and organizational skills.
Published
November 11, 2021
Location
Littleton, Massachusetts
Category
Medtech  
Job Type
Only registered members can apply for jobs.
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