Hyalex Orthopaedics

VP of Research and Development

Hyalex Orthopaedics is an early-stage, venture-backed medical device company seeking an experienced R&D leader to join its executive team. 

You will have the opportunity to:

• Build and lead a world-class research and development team
• Improve patient outcomes and ultimately change the standard of care in orthopaedics
• Meaningfully impact the company's short-term and long-term success
• Work closely with executives internally and externally as well as thought-leaders in the field globally
• Become an expert in the areas of advanced biomaterials, cartilage, osteoarthritis and orthopaedics
• Grow your role as you see fit
• Create an inspiring workplace

THE ROLE

• Align, structure, motivate and lead a team of highly motivated, world-class development engineers and scientists to deliver on the strategic plan
• Build a culture of teamwork and excellence in a fast-paced, lean environment
• Work with healthcare KOL's to generate and refine product specifications
• Contribute significantly to the overall pipeline and portfolio strategy
• Deliver programs on time and on budget
• Generate required documentation including timelines, budgets, specifications, testing protocols, and risk analysis
• Own the design control system and assure complete compliance with all requirements
• Prepare documentation for regulatory submissions and internal quality system
• Develop/coordinate efficient manufacturing processes with third parties
• Establish license and supply agreements with key external vendors in support of the product development objectives
• Coordinate and manage bench studies
• Collaborate on pre-clinical, human factors, and human studies
• Develop ideas into inventions and prepare patent disclosures and support IP portfolio strategy
• Evaluate novel technologies for addition to the company's portfolio
• Maintain current awareness of developments and competitor activity in the medical fields relevant to the company
• Represent the overall research and development perspective where needed in investor presentations, Board meetings and with business and financial partners and in the company's dealings with regulatory authorities.

This position requires a passion for customers, technology innovation, and product and process excellence, as well as a proven track record building and leading high-performing technical teams.

THE PERSON

Requirements

• Strong R&D, pipeline management and clinical experience with medical devices

• Experience successfully commercializing surgical devices

• Sound understanding and relevant experience in supporting clinical studies in the US and Europe

• Strong program management experience

• Demonstrated ability to deliver on time, on budget in a fast-paced lean environment

• Experience with FDA GMP, GLP and design controls

• Experience developing products according to ISO 13485

Ideal candidate will also have experience with:

• Orthopaedics (reconstruction and sports medicine)
• Advanced biomaterials and polymers as permanent implants
• FDA Class III/PMA
• Process development/operations

Education Requirements

• Bachelor's of Science (Masters of Science or PhD Preferred) in Mechanical Engineering, Chemical Engineering, BioEngineering, Material Science, Polymer Science or related field
• 15+ years of related work experience including 5+ years as a people manager

Job Type & Compensation

• This is a full -time role with competitive compensation that is commensurate with experience and provides competitive benefits. Ability to travel 10- 15% required.

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. 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 products.

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.