Manager, Medical Device Quality Engineering

Terumo Neuro; Aliso Viejo (CA); On-site; USD 125,000 - 150,000; Full time

Job summary

Terumo Neuro in the United States seeks a Manager of Medical Device Quality Engineering to lead the Design Quality Engineering team and support R&D product development from concept through release.

You will ensure FDA and ISO 13485 compliance, guide design control activities, and oversee risk analysis, design verification/validation, and process validation across projects.

Qualifications

• Experience leading Design Quality Engineers and Technicians.
• Strong knowledge of FDA regulations and ISO 13485 requirements.
• Expertise in design control, risk management, and design reviews.
• Ability to guide data analysis, verification, and validation activities.

Responsibilities

• Lead and develop Design Quality Engineers and Technicians across projects.
• Guide teams through design control processes per FDA and ISO standards.
• Provide leadership in risk analysis, V&V, process validation, and data analysis.
• Mentor engineers on design control activities and project delivery.
• Assess performance, trainer assignments, and talent development.
• Lead New Product Development, PLM, sustaining engineering, and KTBR projects.

Skills

People leadership

Quality Assurance

Design Control

Regulatory Compliance

Statistical Analysis

Job description

Manager, Medical Device Quality Engineering

Position Overview

Lead multiple quality-related initiatives. Manage Design Quality Engineers and Technicians who support the development and manufacture of medical devices. Directly support and lead assigned R&D product development projects, design changes and design improvements, and KTBR (Keep the Business Running) initiatives as the Design Quality Engineer representative in the Core Team, while simultaneously managing the Design Quality Engineering team. Work with R&D, Manufacturing, and Production Quality Engineers to ensure the Design Quality engineering support for the resolution of product quality issues and provide technical expertise. Ensure regulatory compliance with applicable FDA, ISO 13485, and worldwide regulatory requirements. Job duties:

• Lead and develop direct reports with varying technical experience from entry to senior level roles including task assignment, review, coaching, and mentoring.
• Assist product development teams in following the design control process. Ensure that teams follow design control processes defined in applicable FDA regulations, international requirements, and Company procedures.
• Provide leadership in technical aspects of quality assurance including risk analysis, design verification, design validation, process validation, test method validation, and data analysis.
• Manage Quality Engineers supporting R&D product development. Independently lead assigned development projects while providing direct design quality support throughout the design control process. Mentor and coach engineers on design control activities.
• Ensure adequacy of Quality Engineers by assessing performance, providing individualized training, providing appropriate assignments, and evaluating potential candidates.
• Instruct Design Quality Engineers to appropriately use statistical methods such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, design of experiments, gauge repeatability and reproducibility, etc. to inform decision making and conclusions.
• Serve as the Design Quality Lead for assigned New Product Development (NPD), Product Lifecycle Management (PLM), sustaining engineering, cost improvement, supplier change, and KTBR projects from concept through commercial release.
• Independently perform Design Quality Engineering activities, including development and review of Design and Development File (DDF) documentation, risk management, design verification and validation, process validation, test method validation, statistical analysis, engineering change assessments, and resolution of technical quality issues.
• Provide hands-on technical leadership to R&D teams by participating in design reviews, evaluating technical decisions, identifying quality and regulatory risks and proposing solutions, and ensuring compliance with FDA regulations, ISO 13485, IEC 62366-1, ISO 14971, and applicable country-specific standards and company procedures.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Job ID 14508BR

Salary Range:

$125,123 - $150,224 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)