Senior Engineer, Advanced Quality (Onsite)

As the Senior Engineer, Advanced Quality you will support quality engineering throughout new product development. In this role, you will lead design quality activities across risk management, reliability engineering, human factors, design verification and validation, and process validation while partnering with Engineering, Manufacturing, and Product Development teams to ensure products meet applicable quality and regulatory requirements.

What You Will Do

• Lead quality engineering activities for new product development, ensuring compliance with FDA Quality System requirements, ISO 13485, and internal quality standards.
• Lead product risk management activities, including risk analysis, failure mode evaluation, risk mitigation, and assessment of product reliability.
• Apply quality engineering tools and statistical methods to evaluate components, assemblies, processes, and finished products throughout design and development.
• Lead human factors engineering and design validation activities to verify products meet defined user needs, intended uses, and safety requirements.
• Develop reliability testing strategies, including accelerated test methods and correlation of test results with expected field performance.
• Support design verification, process validation, manufacturing process development, and inspection methods for components and finished products.
• Partner with Research & Development, Manufacturing, Product Engineering, and other cross-functional teams to review technical deliverables and resolve quality issues throughout development.
• Support nonconformance and corrective and preventive action investigations using structured problem-solving, root cause analysis, and appropriate corrective action methods.

What You Need

Required

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Science, or a related discipline.
• Minimum 2 years of full-time work experience in Quality Engineering, Technical Engineering, Product Development, or a related engineering role within a research and development or manufacturing environment.
• Experience applying quality engineering methods within product development or manufacturing processes.

Preferred

• Minimum 1 year of experience in Advanced Quality Engineering, Design Quality Engineering, or a related new product development quality role.
• Experience working within a regulated medical device or other regulated manufacturing environment.
• Experience applying ISO 13485, Good Manufacturing Practice, and Good Documentation Practice requirements.
• American Society for Quality Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Six Sigma Black Belt (CSSBB), or equivalent training or experience.
• Training or certification in Geometric Dimensioning and Tolerancing (GD&T).