Principal Design Engineer
Hyalex Orthopedics is seeking candidates for a Principal Design Engineer position. The Principal Design Engineer will report directly to the VP of R&D and will 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
- Bachelor of Science in Mechanical Engineering (MS preferred)
- 10+ 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)
Hyalex Orthopaedics is an early stage, venture funded medical device company focused on developing and commercializing new products that feature HYALEX™ materials technology. The HYALEX technology is poised to change the orthopaedics industry through materials innovation and improved patient quality of life. The Hyalex team is comprised of industry leaders, R&D innovators, and experts who have launched multiple successful commercial products as well as a team of brilliant engineers and scientists who aren't afraid to ask questions, think outside the box and challenge the existing status quo in pursuit of excellence and breakthrough discoveries.
Hyalex values are focused on teamwork, communication, innovation, integrity, and accountability and all team members strive to promote an inspirational and productive workplace. Every team member's contribution is valued as we work towards a common goal of transforming the orthopaedic space.