Senior R&D Engineer, Tioga Medical


ABOUT SHIFAMED

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.

As Shifamed’s portfolio of companies continues to expand, we are looking for creative medical device engineering talent interested in working in a fast-paced and innovative environment.

JOB POSITION

Senior R&D Engineer, Tioga Medical

POSITION DESCRIPTION

Tioga Medical is an early stage Shifamed portfolio company developing a next-generation percutaneous replacement mitral valve. We are currently looking for a hands-on engineer who is a creative thinker, problem-solver, collaborative team player and active in their approach to concept generation and execution. This position represents an exciting opportunity to join the Tioga team in its early stage and help us develop a product from proof of concept to being ready for clinical use.

As a Senior R&D Engineer on the Tioga team, you will play a key role in the product’s design and development, process development and optimization, and verification & validation testing to support the product’s clinical use.

POSITION RESPONSIBILITIES

Including but not limited to:

  • Hands-on prototyping and development of device, processes and tests
  • Work as part of a cross-functional team to develop and evaluate product designs through verification and validation testing
  • Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions
  • Provide periodic updates regarding project status
  • Contribute to the company’s intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice
  • Interact with physicians regarding product development, testing, and product demonstrations
  • Train other team members on product assembly; troubleshoot assembly process issues

REQUIRED SKILLS, ABILITIES & EXPERIENCE

  • Proficient in design and development of catheter-based medical devices
  • Proficient in CAD design and documentation software; SolidWorks and 3D printing preferred
  • Experience in designing and making test and process fixtures and equipment
  • Basic machine shop skills
  • Experience with Nitinol processing, injection molding, and packaging design a plus
  • Demonstrated ability of working with suppliers, including understanding of capabilities, materials, and fabrication processes
  • Knowledgeable about medical device regulations
  • Experience working in a lab and CER
  • Excellent communication skills; ability to work both independently and in project team setting
  • Ability to travel

REQUIRED EDUCATION & WORK EXPERIENCE

  • BS degree in Mechanical, Biomedical, Industrial, or Manufacturing Engineering
  • 5+ years’ work experience, in the medical device industry preferred

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