Sr. Design Engineer

EXALTA Group brings together three industry pioneers under one banner (Intech, Resolve Surgical, and Tyber Medical), reinforcing a shared objective: advancing the future of MedTech with greater clinical impact and improved patient outcomes. New website: https://exalta.com/. Our Bethlehem, PA location is part of the Integrated OEM Solutions business unit.

Location: On-site, Bethlehem, PA

Develop new medical devices and/or make enhancements to existing products through regular interaction with a cross-functional team.  The Sr. Design Engineer must also assist with relevant development processes and conform to the guidelines described in the company’s quality system and other policies.    

Primary Job Responsibilities: 

• Research and develop surgical implants and instruments in accordance with regulatory and quality requirements. 
• Create 3D part files and 2D technical drawings using SolidWorks. 
• Analyze test data and generate reports to verify or validate that designs meet functional and performance specifications. 
• Interact and coordinate with other departments to establish project plans, product requirements, and other documentation activities in accordance with design control and risk management procedures. 
• Provide assistance to the Manufacturing, Supply Chain, Quality and Regulatory departments as needed. 
• Interface with suppliers and provide support during the manufacturing process. 
• Follow organizational and group guidelines, procedures, protocols. 
• View surgical procedures in operating room or cadaver lab. 
• Present and share information with management, customers, and/or field personnel when requested (PowerPoint skills preferred). 
• Independently lead/execute project deliverables and manage multiple tasks at once. 
• Promote and ensure continual improvement in all interacting departments. 
• Communicate effectively to ensure project team and senior management are aware of upcoming milestones and risks/issues. 

Secondary Job Responsibilities: 

• Inspect inventory components and supervise first product builds 
• Support business development and management activities 
• Participate in research assignments including trade show and other conference attendance 
• Respond to field questions related to products and projects when necessary  

Educational Requirements:  BS in engineering (mechanical and/or biomedical a plus) or equivalent work experience. 

Experience Requirements: 2-years product development experience in medical device desired. 

Reports to: Sr. Project Engineer or equivalent