Hyalex Orthopedics is seeking candidates for a Principal Design Engineer position. The Principal Design Engineer will be the captain and a key player on Hyalex Orthopaedics' design team, reporting directly to the VP of R&D. The successful candidate will have a wide range of medical 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 for innovative orthopaedic devices and instruments from concept to clinic
• Manage and mentor internal design engineers and external design consultants
• 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
• Help design and perform mechanical testing for proof of concept
• Write testing 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/SKILLS/WORK EXPERIENCE:

• 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)
• Finite element analysis (FEA) experience preferred
• Leadership
• Development and testing of surgical instruments and tools
• Regulatory submissions (FDA and CE) and audit support
• Creating DHFs and working within design controls (ISO 13485)
• Fluent in OR environment – has attended a large number of surgeries and surgical labs
• Managing surgeon and other health care professional (HCP) relationships
• Establishing  project plans and priorities
• Strong technical writing skills
• Clear communicator capable of tailoring information for different audiences
• Able to define problems, establish facts, and utilize critical and logical reasoning to draw valid, viable conclusions
• Hands on with a bias for action, positive, energetic, self-motivated (very important)

ABOUT HYALEX

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 include 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.