Quality Engineer (Medical Devices)

Location: Orange County, California; onsite with the Laguna Niguel team

Salary: $90,800–$151,300 per year

Company

hirify.global develops and manufactures medical devices and components, including Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.

What you will do

• Ensure compliance with customer, risk management, quality, and design-control requirements across product development projects.
• Support successful design transfer to manufacturing and develop quality and regulatory standards for medical device materials and products.
• Implement inspection, testing, and evaluation methods for products and production equipment.
• Lead risk-management documentation, including risk plans and reports, hazard analyses, FMEAs, design traceability matrices, and post-market surveillance plans.
• Develop process validation protocols and reports, support design of experiments, and analyze process data.
• Investigate manufacturing and quality-system issues, field complaints, SCARs, CAPAs, and nonconformances; support customer and notified-body audits.

Requirements

• BS in a related engineering discipline with 5 years of relevant medical-device quality experience, or MS with 4 years of experience.
• At least 5 years of experience in medical device product development.
• At least 5 years of experience with FDA, ISO 13485, and EU MDR design-control requirements.
• Practical knowledge of ISO 14971 and risk-management requirements.
• Strong statistical analysis skills using Minitab, including process capability, normality assessments, ANOVA, hypothesis testing, sample-size determination, tolerance intervals, sampling plans, DOE, and response-surface models.
• Competence with Microsoft Office applications.

Culture & Benefits

• Collaborative work with customers and cross-functional engineering, manufacturing, and quality teams.
• Competitive compensation and benefits.
• Work focused on taking medical device concepts from rapid prototype through high-volume production.
• Employment visa sponsorship is not available, and candidates on time-limited visas will not be considered.