Senior Medical Device Mechanical Engineer - VAD Systems

Spectraforce Technologies; Pleasanton (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Spectraforce Technologies is seeking a Sr. R&D Mechanical Engineer in Pleasanton, CA to provide technical leadership for sustaining products in Class II/III medical devices, including VADs and cardiovascular implants.

You will lead complex investigations, drive improvements, and ensure regulatory compliance across R&D, Quality, Regulatory, and Manufacturing teams. The role requires extensive collaboration, strong GD&T and mechanical design expertise, and the ability to travel ~10%.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field.
• 15+ years in Class II/III medical devices including development, sustaining, V&V, manufacturing support, and risk management.

Responsibilities

• Provide technical leadership across sustaining initiatives for Class II/III devices.
• Lead complex investigations using root cause analysis for field issues and complaints.
• Develop, test, and sustain mechanical and electromechanical systems for cardiovascular products.
• Drive cross-functional improvements across product lifecycle including reliability and manufacturability.
• Apply experimental, analytical, and numerical methods to support engineering decisions.

Skills

Technical leadership

Root cause analysis

GD&T

Mechanical design

Risk management

Communication

FDA Design Controls

Travel readiness

Education

Bachelor's degree in Mechanical/Biomedical Engineering

Master's degree in Mechanical/Biomedical Engineering

Tools

CAD systems

DOE

SPC

Six Sigma

Job description

Spectraforce Technologies is seeking a Sr. R&D Mechanical Engineer in Pleasanton, CA to provide technical leadership for sustaining products in Class II/III medical devices, including VADs and cardiovascular implants.

You will lead complex investigations, drive improvements, and ensure regulatory compliance across R&D, Quality, Regulatory, and Manufacturing teams. The role requires extensive collaboration, strong GD&T and mechanical design expertise, and the ability to travel ~10%.