Sr. Equipment Engineer, Supira Medical


ABOUT SHIFAMED AND SUPIRA MEDICAL

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Supira Medical is an early stage Shifamed portfolio company developing a next-generation percutaneous ventricular assist device.

Sr. Equipment Engineer, Supira Medical

POSITION DESCRIPTION

We are currently looking for a hands-on Sr. Equipment Engineer with a hardware and software background who has strong analytical skills and is a collaborative team player. This position represents an exciting opportunity to join the Supira team in its early stage and help us develop a product from proof of concept to being ready for clinical use.

As a Sr. Equipment Engineer on the Supira team, you will play a key role working with product development engineers to develop the systems used for verification & validation efforts, supporting the product’s design and development for clinical use.

RESPONSIBILITIES

Including but not limited to:

  • Work with product development team to develop and implement test fixtures, automated test methodologies, data collection systems, and small-volume manufacturing equipment to support design verification and validation activities; both hardware and software
  • Create and maintain design documentation (CAD files, BOMs, basic PCB layouts, etc.) and related work instructions, test methods, and IQ/OQ/PQ documents as needed
  • Manage all associated equipment for calibration and preventative maintenance
  • Manage tasks related to multiple projects
  • Work as part of a cross-functional team to create, evaluate, verify and validate product designs through bench, in-vitro, and in-vivo testing
    • Analyze test results in relation to specifications and test objectives
    • Present results in numerical and graphical form to make data driven decisions
  • Contribute to the intellectual property position of the company via lab notebook documentation, invention disclosures and prototypes to demonstrate reduction to practice. Participate in technical “brainstorming” sessions to generate new intellectual property

REQUIREMENTS

  • Demonstrated success in developing hardware and software used in the testing or manufacturing of medical devices or other high-tech, regulated products
  • Strong knowledge of SolidWorks for fixture design
  • Strong programming skills; including common software architectures like state machines, producer-consumer, master-slave; LabVIEW experience preferred
  • Experience with data acquisition systems; National Instruments preferred
  • Experience with various sensors and their calibration; pressure, volumetric flow, temperature, vibration, accelerometers, LVDTs, etc.
  • Experience with motion control systems; steppers, servos, linear actuators, pneumatics, valves, etc.
  • Experience with commercial hardware communication via standard protocols; RS-485, gigabit, modbus, I2C, etc.
  • Experience with software source control in a multi-user environment; GIT, Bitbucket, JIRA, or similar
  • Integrating industrial vision systems into testing/mfg equipment for machine vision or metrology a plus
  • Strong documentation ability; familiarity with regulatory compliance, e.g. ISO 13485 and IEC 62304, is a plus
  • Experience with Python, relational databases, MS Access, and VBA are a plus
  • Excellent communication skills; ability to work independently or in project team setting
  • Ability to travel
  • BS degree in Mechanical, Biomedical, or Electrical Engineering or related technical field
  • 5+ years direct work experience in a high-tech industry

Please email your résumé and details to: hr@shifamed.com.