Lead Mechanical Engineer, MedTech Sustaining Systems

The Fountain Group; Pleasanton (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

The Fountain Group is seeking an experienced Mechanical/ Biomedical Engineer to lead sustaining activities for Class II/III medical devices in Pleasanton, CA. You will guide investigations, drive improvements, and ensure compliance across R&D, Quality, Regulatory, and Manufacturing teams.

Candidate has 10+ years in medical devices, expertise in GD&T, risk management, and product development, with strong cross-functional leadership and communication skills.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field.
• 10+ years of progressively increasing engineering responsibility in Class II/III medical devices.
• Expertise in mechanical design, tolerance analysis, GD&T, materials, manufacturing processes, and assembly.
• Demonstrated cross-functional leadership and ability to influence technical decisions without direct authority.
• Strong understanding of FDA Design Controls, 21 CFR Part 820, medical device development processes.
• Experience leading complex investigations and root cause analyses.
• Experience with risk management principles, including FMEA.
• Strong written, verbal, presentation, and technical communication skills.

Responsibilities

• Provide technical leadership across sustaining initiatives for Class II and Class III medical devices.
• Lead complex investigations associated with product performance, complaints, CAPAs, nonconformances, and field issues using root cause analysis.
• Research, develop, test, and sustain mechanical and electromechanical systems for VADs, extracorporeal pumps, oxygenators, and related products.
• Drive cross-functional efforts to identify, assess, and implement product, process, and reliability improvements.
• Apply experimental, analytical, empirical, and numerical methods to evaluate product performance and support decisions.
• Develop test strategies, methods, and protocols to evaluate system and component performance.
• Design, develop, qualify, and validate equipment and fixtures for verification, reliability testing, and failure analysis.
• Identify technical risks and drive mitigation strategies.
• Analyze data to identify trends and drive continuous improvement.
• Create and review engineering drawings and specifications for dimensioning, tolerancing, manufacturability, and assembly.
• Perform tolerance analyses and stack-ups for robustness and manufacturability.
• Provide expertise in GD&T and mechanical design principles.
• Support design reviews and mentor engineers across disciplines.
• Evaluate manufacturing processes including machining, molding, welding, extrusion, and assembly methods.
• Collaborate with regulatory, quality, and clinical teams for submissions and audits.
• Ensure compliance with FDA regulations and QMS requirements.
• Support continuous improvement of engineering processes and product quality.

Skills

Mechanical design

GD&T

Root cause analysis

Risk management

FDA Design Controls

Cross-functional leadership

Manufacturing support

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

FEM/FEA

Job description

The Fountain Group is seeking an experienced Mechanical/ Biomedical Engineer to lead sustaining activities for Class II/III medical devices in Pleasanton, CA. You will guide investigations, drive improvements, and ensure compliance across R&D, Quality, Regulatory, and Manufacturing teams.

Candidate has 10+ years in medical devices, expertise in GD&T, risk management, and product development, with strong cross-functional leadership and communication skills.