Senior Manager, Medical Device Quality Engineering

Terumo Neuro; Aliso Viejo (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Terumo Neuro is seeking a Manager, Medical Device Quality Engineering to lead a team of Design Quality Engineers and Technicians responsible for development and manufacturing of medical devices. You will guide design controls, risk analyses, and regulatory compliance across FDA/ISO standards while collaborating with R&D and manufacturing teams.

You will mentor staff, manage projects from concept to release, and drive continuous quality improvements in a fast-paced environment.

Qualifications

• Bachelor’s degree in science or engineering.
• Minimum six (6) years in the medical device engineering field.
• Minimum one (1) year in a leadership or supervisory role.
• Strong ability to read, prepare, and review technical documents.
• Excellent written and verbal communication skills.
• Strong interpersonal and management skills.
• Proficient in MS Word, Excel, Outlook, Teams, and Minitab.

Responsibilities

• Lead quality initiatives and manage Design Quality Engineers and Technicians.
• Support and lead R&D product development projects and design changes.
• Ensure regulatory compliance with FDA, ISO 13485, and global standards.
• Provide technical leadership in QA activities including design verification/validation and risk analysis.
• Mentor and coach team members across design control processes.
• Collaborate with R&D, Manufacturing, and Production Quality Engineers to resolve quality issues.
• Oversee documentation like DDFs and risk management throughout design control.
• Drive process improvements and KTBR projects from concept to release.
• Ensure adherence to quality systems, ethics, and company procedures.

Skills

Leadership

Mentoring

Documentation

Communication

Statistical analysis

Minitab

MS Office

Education

Bachelor’s degree in science or engineering

Tools

Minitab

MS Word

Excel

Outlook

Teams

Job description

Terumo Neuro is seeking a Manager, Medical Device Quality Engineering to lead a team of Design Quality Engineers and Technicians responsible for development and manufacturing of medical devices. You will guide design controls, risk analyses, and regulatory compliance across FDA/ISO standards while collaborating with R&D and manufacturing teams.

You will mentor staff, manage projects from concept to release, and drive continuous quality improvements in a fast-paced environment.