Lead Heart Valve and Class III Medical Device Development Engineer

3 days ago


Santa Ana, California, United States Entegee Full time

Job Overview:

Entegee is a leader in custom automation projects, providing cutting-edge controls and robotic solutions globally. We are seeking an experienced Senior Engineer to lead the development of heart valves and Class III medical devices.

Key Responsibilities:

  • Design, develop, and analyze heart valves and delivery systems
  • Lead technical investigations and troubleshooting efforts during research and product development
  • Conduct studies to investigate specific life science questions within the field of expertise
  • Oversee heart valve testing, including PIV, AWT, Migration, DFM, and Hydro testing
  • Perform material testing and analysis to ensure product reliability and safety
  • Apply engineering first principles to innovate within the Structural Heart and Aortic product lines

Requirements:

  • Bachelor's degree in Engineering with 5+ years of experience
  • 3+ years of experience with heart valves and Class III medical devices
  • Expertise in Root Cause Analysis
  • Knowledge of materials, including metals, polymers, sutures, and tissues
  • Mechanical Engineering background
  • Strong expertise in heart valve testing, including PIV, AWT, Migration, DFM, and Hydro testing
  • Understanding of corrosion and wear mechanisms
  • Experience with material testing and analysis

PREFERRED SKILLS:

  • Familiarity with engineering first principles in the context of structural heart and aortic device development
  • Experience in translating research discoveries into marketable products
  • Involvement in product research and development and/or clinical trials

Salary Range: $50-$65 per hour

Benefits:

  • Medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and 401K plan
  • Paid leave, including Paid Sick Leave and Holiday pay where applicable

Equal Opportunity Employer:

Entegee is an Equal Opportunity Employer and welcomes applications from diverse candidates. Our company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements.



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