Senior Medical Device Engineer
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 Senior Medical Device Engineer will be responsible for developing and conducting preclinical testing for orthopaedic products to characterize the 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 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, Research and Development.
Duties and Responsibilities
- Manage biocompatibility and biostability testing for novel biomaterials
- Conduct in vivo device evaluations
- Supervise external laboratories performing GLP and non-GLP studies
- Develop and perform mechanical testing of materials and devices
- Analyze data, including statistical analyses
- Collaborate with cross-disciplinary teams and external groups to coordinate and drive complex studies
- Develop and author SOPs, IACUC protocols, study protocols, reports and other engineering and quality documents
- Travel to study sites and testing labs to support study execution and monitor progress
- Present data at internal and external meetings
- Other duties as assigned
Qualifications/Work Experience
- MS or PhD in Mechanical Engineering, Bioengineering or similar background required
- 10 years’ work experience with at least 5 years of experience in medical device preclinical testing, orthopaedics and/or sports medicine experience
- Working knowledge of histology, clinical imaging methods, and musculoskeletal anatomy with a focus on orthopaedics preferred
- Experience working directly with surgeons conducting hands-on demonstrations, training, cadaver labs
- Exceptional analytical, problem solving and organizational skills with attention to detail
- Demonstrated ability to develop and conduct mechanical testing
- Experience with Design Controls and ISO 13485 quality system requirements
- Professional written and oral communication skills
- Experience with supporting 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, dental and vision benefits
- Pre-tax savings plans for healthcare
- 401(k) retirement plan
- Generous paid time off (PTO)
- Short-term and long-term disability insurance and an employee assistance program
- Life and AD&D insurance
- 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.
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.