Reporting to the Director of Engineering, the Manufacturing Engineer will assist in establishing and converting pilot scale physical and chemical processes to a full scale, quality-controlled production systems that complies with medical device manufacturing directives. Additionally, he or she will directly interact with product development on design optimization as it relates to manufacturability.
Roles 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
- Assist with process validation activities
- Development and release of all product and process documentation, drawings and incoming inspection requirements
- Assist in the planning and coordination of all development activities to launch and commercialize new products
- Lead the execution of validation projects and/or protocols and the collection of data to support completion of Process Validation activities
- Maintains good documentation practices for all forms, logs, appendices, protocols, reports, and laboratory notebooks.
- Qualification / Work Experience
- BS in Chemical Engineering
- 4-8 years of experience with manufacturing/processing of medical devices
- Experience designing and building manufacturing fixtures and integrated process equipment
- Experience with CAD (SolidWorks preferred)
- Broad knowledge of and experience in working in ISO 13485/GMP and clean-room manufacturing/process environment a plus
- Preferred experiences include polymer processing, operation of controlled mixing processes, sterile filtration, operation of motion control/controlled temp/controlled pH systems, device sterilization and packaging
- Strong written and verbal communication skills
- Self-motivated, hands on, strong work ethic, independent, creative
- No relocation assistance offered.
- Permanent resident or US citizen
Health Insurance Short / Long Term Disability
Dental Insurance Paid Time off
Health Savings Account (HSA) Paid Holidays
Retirement Plan Paid Parental Leave
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 discoveries.
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.