Process Development Engineer
Process Development Engineer
This position will work very closely with our lead process engineer and 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. In addition, this position will directly interact with product development on design optimization as it relates to manufacturability.
• 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 design & process verification and 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
Education and Experience
• BS in Chemical, Plastics, Polymer or Materials Engineering
• At 1-4 years’ experience with manufacturing, processing, design or other engineering/technical roles related to wet chemistry
Knowledge, Skills and Abilities
• Experience designing and building manufacturing fixtures and integrated process equipment
• Experience with CAD (SolidWorks preferred), machining, and prototyping of electro-mechanical designs, automation-control skills is a plus
• Broad knowledge of and experience in working in ISO 13485/GMP and clean-room manufacturing/process environment a plus
• Strong written and verbal communication skills
• Self-motivated, hands on, strong work ethic, independent, creative
• Local candidates only
• Permanent resident or US citizen About Hyalex
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.
Send Resume to: Marzena@hyalex.com Or Apply here: https://hyalex.breezy.hr/p/08b32061c5ef-manufacturing-and-development-engineer
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