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 new product introduction Manufacturing Engineer assists in establishing and converting pilot scale physical and chemical processes to full scale, quality-controlled production systems that comply with medical device manufacturing directives for the introduction of new products. This position will work closely with our process engineering team and will also interact with our product development team on design optimization as it relates to manufacturability. This is an excellent opportunity for the selected candidate to be a hands-on participant in building the future of Orthopaedics. This role will report to the Director of Manufacturing Engineering.

Role and Responsibilities

  • Design, build and qualify prototype, pilot, and full-scale manufacturing fixtures
  • Assist in the manufacturing of pre-clinical and clinical implants, which includes wet chemistry processes, raw material management, inspection and packaging
  • Work with suppliers to develop cost effective custom component designs
  • Assist with process validation activities (IQ/OQ/PQ)
  • Develop and release process documentation, drawings and incoming inspection requirements
  • Other duties as assigned

Qualifications/Work Experience

  • BS/MS in Chemical Engineering preferred, Polymer Science or Materials Science Engineering backgrounds will also be considered
  • 1 - 5 years of experience with manufacturing, processing, design or other engineering/technical roles related to wet chemistry
  • Must have prior corporate work experience outside of a University environment
  • Experience with CAD (SolidWorks preferred), machining (lathe/mill), other fabrication tools, and prototyping of electro-mechanical designs, automation-control skills is a plus
  • Experience with polymer processing, operation of controlled mixing processes, sterile filtration, operation of motion control/controlled pH systems, device sterilization and packaging a plus
  • Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data
  • Broad knowledge of and experience working in an ISO 13485/GMP environment
  • Clean-room manufacturing/process environment experience
  • Strong written and verbal communication skills
  • Self-motivated, hands on, strong work ethic, independent and creative
  • Local candidates only

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 plan for healthcare
  • 401(k) retirement plan
  • Generous paid time off (PTO)
  • Short-term and long-term disability insurance and an employee assistance program
  • Tuition reimbursement
  • Paid parental leave
  • 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.