The Mechanical Engineer V, Manufacturing 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 supports manufacturing and will be responsible to develop highly capable manufacturing processes, to optimize manufacturing processes and to optimize design for manufacturability.

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

Duties and Responsibilities

  • 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.
  • Develops, implements, verifies and validates manufacturing and product acceptance test procedures.
  • Optimizes factory layout and minimize non-value add activities.
  • Develops, implements, and manages product quality and process control systems.
  • 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.
  • Will be responsible to optimize design for manufacturability.
  • Will write protocols, execute, gather data, analyze the results, and write reports.
  • Manages, tracks progress, and reports on project status.

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 have advanced mechanical and fluid mechanics analytical skills.
  • Must have advanced statistical analytical skills.
  • Must be proficient with MS 365 tools.
  • Must have good oral and written communication skills.
  • Must have project management and team leadership experience.
  • A strong background in Lean Manufacturing tools and techniques is a plus.
  • Experience in principles of design for repeatability and precision and constraint theory is a plus.
  • The capability to apply valid industrial research methods, a developed understanding of variation, and applied statistics knowledge are preferred.
  • Must have experience working within medical device regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) and work must conform with the Quality Management System.

Direct Reports

TBD

Additional Information

Reports to VP Operations

Works in an office, manufacturing facility, laboratory and clean room.