Senior Design Assurance Engineer – Medical Devices

New-World-Medical-; Rancho Cucamonga (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with profit share

Bonus opportunities

Career development program

Tuition assistance

Cell phone stipend

Wellness & EAP

Company events

Job summary

New World Medical is seeking a Principal Engineer, Quality – Design Assurance in California. Lead design controls, risk management, and V&V across the product lifecycle. Collaborate across R&D, Regulatory, Manufacturing, and Operations to ensure QMS, FDA QMSR, and ISO 13485 compliance.

Mentor teams and drive continuous quality improvements. Responsibilities include defining testable requirements, ensuring traceability, reviewing verification strategies, and guiding design transfer and

Qualifications

• Expert in design controls, risk management, verification/validation.
• Strong FDA QMSR, ISO 13485, ISO 14971 knowledge.
• Proven cross-functional leadership and risk-based decisions.
• Strong technical writing for protocols and reports.
• Statistical methods knowledge using Minitab or equivalent.

Responsibilities

• Provide design assurance leadership across product lifecycle.
• Define testable requirements with traceability.
• Oversee risk management per ISO 14971 and procedures.
• Lead phase and design reviews, document actions.
• Oversee QA for clinical/investigational builds and changes.
• Review V&V strategies, protocols, reports, criteria.
• Support qualification/validation of inspection methods.
• Collaborate with Regulatory Affairs on new products.
• Support changes to products, suppliers, processes.
• Mentor on design controls, risk, and quality engineering.

Skills

Design controls

Risk management

Regulatory knowledge

Quality engineering

Technical writing

Statistics (Minitab)

Cross-functional leadership

Problem solving

Project management

MS Office (Word, Excel, PPT)

Education

Bachelors in engineering/science

7+ years medical devices

ASQ/RAPS certs preferred

Tools

Minitab

MS Office Suite

Job description

New World Medical is seeking a Principal Engineer, Quality – Design Assurance in California. Lead design controls, risk management, and V&V across the product lifecycle. Collaborate across R&D, Regulatory, Manufacturing, and Operations to ensure QMS, FDA QMSR, and ISO 13485 compliance.

Mentor teams and drive continuous quality improvements. Responsibilities include defining testable requirements, ensuring traceability, reviewing verification strategies, and guiding design transfer and