Senior Director, Quality Engineering – Medical Devices

BiVACOR Inc; Huntington Beach (CA); On-site; USD 155,000 - 169,990; Full time

Job summary

BiVACOR Inc is seeking a Senior Manager for Quality Engineering to lead quality functions throughout the product lifecycle of the Total Artificial Heart system. This role requires a visionary leader with deep experience in electrical engineering and AIMD. Responsibilities include strategic QMS vision, team development, and regulatory interaction.

With over 18 years in the medical device industry, the ideal candidate will have extensive involvement with Class III devices and a solid track record in quality engineering leadership.

Located in Huntington Beach, California, this position offers a competitive salary and opportunity to impact patient lives.

Qualifications

• Minimum 18 years of experience in the medical device industry.
• Direct experience with Class III Active Implantable Medical Devices (AIMD).
• IPC-A-610 and/or IPC-A-620 certification preferred.

Responsibilities

• Define and execute strategic vision for the QMS.
• Lead and develop a high-performing quality engineering team.
• Oversee test method validation and equipment qualification.

Skills

Electrical Engineering

Quality Engineering Leadership

Regulatory Compliance

Risk Management

Education

Bachelor's degree or higher in Electrical Engineering

Tools

ISO 13485

FMEA

Lean Six Sigma

Job description

BiVACOR Inc is seeking a Senior Manager for Quality Engineering to lead quality functions throughout the product lifecycle of the Total Artificial Heart system. This role requires a visionary leader with deep experience in electrical engineering and AIMD. Responsibilities include strategic QMS vision, team development, and regulatory interaction.

With over 18 years in the medical device industry, the ideal candidate will have extensive involvement with Class III devices and a solid track record in quality engineering leadership.

Located in Huntington Beach, California, this position offers a competitive salary and opportunity to impact patient lives.