Medical Device Development 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 Medical Device Development Engineer will be responsible for helping to develop and test innovative medical devices including implants and instrumentation. The role will include developing the designs and conducting testing for orthopaedic products to characterize the mechanical and functional performance. This position will require hands-on activities in the Hyalex Orthopaedics laboratories and will interact with external laboratories or vendors. The role will interface with the Manufacturing team to conduct product evaluations.
Duties and Responsibilities
- Develop and perform mechanical testing of materials and devices including working with external facilities where appropriate.
- Design, prototype and source devices and fixtures for use in testing.
- Create design documentation including drawings, models and specifications.
- Analyze data, including statistical analyses
- Collaborate with cross-disciplinary teams to ensure proper transfer of designs from development to manufacturing.
- Develop and author SOPs, study protocols, reports and other engineering and quality documents
- Travel to study sites and testing labs to support study execution and monitor progress
- Providing proof of full COVID-19 vaccination status. While the Company will consider accommodations for disability- and religious- based reasons, vaccination is generally considered a necessary attribute of the position.
- Other duties as assigned
Qualifications/Work Experience
- BS or MS in Mechanical Engineering, Bioengineering or similar background required
- 5-10 years’ work experience with at least 5 years of experience in a role developing medical devices, orthopaedics and/or sports medicine experience
- Exceptional analytical, problem solving and organizational skills with attention to detail
- CAD (e.g., SolidWorks) and GD&T experience
- Experience conducting FEA studies preferred
- Demonstrated ability to develop and conduct mechanical testing
- Experience with Design Controls and ISO 13485 quality system requirements
- Excellent professional written and oral communication skills
- Experience with supporting regulatory submissions (CE/FDA)
- Experience working directly with surgeons conducting hands-on demonstrations, training, cadaver labs
- Working knowledge of musculoskeletal anatomy preferred
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
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.