Preclinical Engineer/Scientist

Hyalex Orthopaedics is an award winning, venture funded medical device start-up developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints. We address unmet clinical needs to improve patient quality of life so that we all can Be Active and Stay Active. Our Hyalex team is comprised of industry leaders, innovators, and experts who have developed and launched many successful commercial products as well as a team of brilliant engineers, scientists and medical professionals.

The Preclinical Engineer/Scientist will be responsible for planning, designing, executing and analyzing preclinical studies for orthopaedic products that include development and execution of material and device characterization testing, including chemical, mechanical, biostability, biocompatibility and functional performance. This position will require hands-on activities in the Hyalex Orthopaedics laboratories and at contract and academic test labs including with CROs. The role will interface with the Product Development and Manufacturing teams to conduct product evaluations and develop the preclinical evidence required to establish product safety and performance. This role will report to the VP of Research and Development.

Role and Responsibilities

  • Manage ISO 10993 biocompatibility testing for novel biomaterials
  • Manage biostability testing for novel biomaterials
  • Manage in vivo device evaluations
  • Supervise external laboratories in conducting GLP and non-GLP studies
  • Analyze data
  • Collaborate with cross-disciplinary teams and external groups to coordinate and drive complex studies to meet desired end points
  • Develop and author SOPs, IACUC protocols, study protocols, reports and other scientific and quality documents
  • Travel to study sites to support study execution and monitor progress
  • Present data at internal and external meetings
  • Other duties as assigned

Qualifications/Work Experience

  • MS/PhD in Mechanical Engineering, Bioengineering or other similar background preferred.
  • 10 years’ work experience with at least 5 years of experience in medical device preclinical testing, orthopaedics and/or sports medicine experience preferred
  • Working knowledge of histology techniques, clinical imaging methods, and musculoskeletal anatomy with a focus on orthopaedics
  • Experience working directly with surgeons conducting hands-on demonstrations, training, cadaver labs.
  • Excellent analytical, problem solving and organizational skills with attention to detail
  • Demonstrated ability to conduct standard mechanical testing
  • Excellent written and oral communication skills
  • Experience with Regulatory submissions (CE/FDA)

Why Hyalex?

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 orthopaedics.

What we offer:

  • Competitive compensation and generous stock options
  • Comprehensive medical and dental benefits
  • Pre-tax savings plans for healthcare
  • 401(k) retirement plan
  • Generous paid time off (PTO) for all employees
  • Paid parental leave
  • Short-term and long-term disability insurance and an employee assistance program
  • The opportunity to work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, on problems that matter in a highly collaborative environment

The health and safety of our team members is our primary concern, especially during the COVID-19 pandemic. Beyond compliance with all local, state and national requirements we have taken additional measures to support the safety of our on-site operations and personnel in Lexington, MA.

Important notice to Employment businesses/ Agencies

Hyalex does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the Hyalex human resources department to obtain prior written authorization before referring any candidates. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Hyalex. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Hyalex. Hyalex shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.