Senior Engineer, Advanced Quality (Onsite)

Stryker is hiring a Senior Engineer, Advanced Quality for our Instruments (Neurosurgical) division. This is an onsite role based in Portage, MI.

 

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).

• USN : $77,700 - $129,500 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.