The Mechanical Engineer V, Product Development designs, develops, and tests all aspects of mechanical components, equipment, and machinery related to development and manufacturing of an active Class III implantable medical device. This job will be responsible to develop and verify a medical device.

TO APPLY: Send Resume/CV and Cover Letter explaining your fit with this position via email to: careers@physiologicdevices.com.

Duties and Responsibilities

  • Will be responsible to develop a robust, easily manufactured, reliable, small, precision medical device that meets performance specifications.
  • Applies knowledge of engineering principles to design products such as engines, instruments, controls, robots, machines, etc.
  • Conducts product testing and creates models and prototypes.
  • Will be involved in fabrication, operation, application, installation, and/or repair of mechanical products.
  • Works on projects/matters of high complexity.
  • Works autonomously.
  • Performs detailed failure analysis on complex, low occurrence issues that will involve interactions and non-linear factors.
  • Writes clear assembly and test procedures.
  • Must know how to write a valid protocol, how to execute a protocol and gather data, how to analyze the results, and how to write a clear and concise report.
  • Manages, tracks progress, and reports on project status.
  • Preferred candidate will have experience working within medical device regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) and will have an understanding of how to maintain compliance with the Quality Management System.
  • Will be responsible to optimize design for manufacturability and to minimize cost to manufacture.

Qualifications

  • Requires a bachelor’s degree of Mechanical Engineering (master’s degree preferred).
  • Typically requires 10+ years of related experience.
  • Must have advanced SolidWorks modeling and drafting skills.
  • Must be proficient with MS 365 tools.
  • Must have good oral and written communication skills.
  • Must have project management and team leadership experience.
  • Developed skills in principles of design for repeatability and precision will be useful.
  • Strong capability to apply valid industrial research methods, a developed understanding of variation, and applied statistics will be useful.
  • Working knowledge of lean manufacturing principles is a plus.

Additional Information

Direct Reports

TBD

Works in an office, manufacturing facility, laboratory and clean room.
Must be able to safely carry light objects (<50 pounds)