Description: Develop new medical devices and/or make enhancements to existing products through regular interaction with a cross-functional team. The 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.
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: 1-year product development experience in medical device desired.