Senior Design Engineer

Hyalex Orthopedics is an early-stage, venture-backed medical device company seeking candidates for a Senior Design Engineer position.  The company is looking for a creative, driven-individual with good hands-on, problem-solving skills who takes pride in his/her work.

The Senior Design Engineer will report directly to the VP of R&D and join Hyalex Orthopaedics’ team with a wide range of device, instrumentation and clinical implementation responsibilities, including working with surgeons, and the design, prototyping, validation and verification of new products using Hyalex’ unique materials platform. This position requires a deep understanding of the orthopaedic device development process from idea to a fully validated, ready-to-use medical device or instrument. This position is uniquely situated at the intersection of medical devices, biomaterials, orthopaedic bioengineering and constitutes a challenging yet intriguing mission in a world of true technological breakthroughs.

 Essential Duties and Responsibilities            

  • Manage and execute design process of innovative orthopaedic devices and instruments
  • Source vendors and oversee manufacturing for surgical instruments
  • Manage and execute V&V of new products (device/instruments)
  • Interact with surgeons and develop training on new devices and instruments
  • Work with quality and regulatory team to support successful regulatory submissions
  • Communicate and interact with clinical advisory board and industry experts
  • Rely on experience and judgment to plan and accomplish goals
  • Perform a variety of complicated tasks
  • Write protocols and reports
  • A wide degree of creativity and latitude is expected. Will need to be resourceful to generate questions and come up with answers

 

Qualifications/Work Experience:   

  • Bachelor of Science in Mechanical Engineering (MS preferred)
  • 7+ years of experience in medical device development (Orthopaedics preferred)
  • Design (CAD), analysis and prototyping skills (SolidWorks preferred)
  • Development and testing of surgical instruments and tools
  • Regulatory submissions (FDA and CE) and audit support
  • Creating of DHFs and working within ISO 13485
  • Fluent in OR environment – has attended a large number of surgeries and surgical labs
  • Management of surgeon and other health care professional (HCP) relationships
  • Hands on, positive, energetic, self-motivated (very important)
  • Available to start immediately

 

About Hyalex Orthopaedics

Hyalex Orthopaedics is an early stage, venture funded medical device company focused on developing and commercializing new products that feature HYALEX™ materials technology. Unlike other polymers, synthetic HYALEX material has the unique capability of maintaining low friction and low wear under the high loads encountered in human joints.

Please apply to Hyalex directly using this link: https://hyalex.breezy.hr/p/2504d1f1b52e