Senior Engineer, Advanced Quality

Stryker is hiring a Senior Engineer, Advanced Quality to support Instruments-Neurosurgical! In this role, you will lead quality engineering initiatives for new product development, driving efforts in reliability engineering, human factors engineering, risk management, and design validation, all while ensuring compliance with FDA Quality System Regulations and ISO 13485 standards.

What You Will Do

• You will be the voice of Quality in a cross-functional team, helping to guide new product development teams through internal quality system requirements to launch new products.
• You will help lead risk management for projects, including risk analysis and development of sound mitigation strategies.
• You will use quality engineering tools, statistical methods, design development methods, process development and control methods, and design verification and validation planning to build quality into new products during development.
• You will help lead Human Factors Engineering activities to develop intuitive and safe new products.
• You will lead design validation efforts to ensure new products meet all customer user needs.
• You will support process validation for new product development to ensure long-term product quality.
• You will develop and create procedures for incoming, in-process and final inspection of components and finished goods.
• You will evaluate project tangibles for technical competence and compliance to ensure we are delivering robust products.
• You may lead NC & CAPA, which require expertise in problem solving and root cause analysis.
  
  

Required

What you need:

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or equivalent discipline is required.
• 2 years of experience in a Technical Engineering or Quality Engineering role within an R&D, quality, or manufacturing environment.
  
  

Preferred

• Previous experience in a regulated environment. Experienced in Medical Device manufacturing with strong familiarity in ISO 13485, GDP, and GMP standards.
• ASQ CQE, CRE, CSSBB or equivalent course work / experience desirable
• Knowledge or certification in GD&T preferred
• Understanding of Med Device manufacturing processes