Senior Quality Engineer (Hybrid)

Stryker; Fremont (CA); Hybrid; USD 101,000 - 168,000; Full time

Job summary

Stryker in Fremont, CA is hiring a Senior Design Quality Engineer to join the Neurovascular division in a hybrid role. You will lead product risk management, post-market surveillance, and design control activities across the lifecycle, driving quality improvements and robust investigations.

In this role you will develop qualification plans, perform validation, conduct risk assessments, and collaborate with regulatory, manufacturing, and engineering teams to ensure safety, performance, and

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Minimum 2 years of experience in engineering, quality engineering, manufacturing engineering, or a related technical role.
• Experience using structured problem-solving methodologies and quality improvement tools.
• Experience supporting product testing, validation, verification, risk management, or process improvement activities.

Responsibilities

• Develop qualification plans, protocols, and reports for new and existing products.
• Execute product testing, inspection, verification, and validation activities.
• Perform failure investigations and root cause analyses.
• Create, maintain, and update product risk management documentation.
• Conduct risk assessments and support design reviews.
• Apply statistical methods to support test method development and investigations.
• Analyze specifications and data to recommend product quality improvements.
• Collaborate with engineering, regulatory, manufacturing, and quality teams.

Skills

Structured problem-solving

Quality engineering

Risk management

Statistical analysis

Education

Bachelor’s degree in Engineering

Job description

Stryker is hiring a Senior Quality Engineer to join our Neurovascular division. This is a hybrid role based in Fremont, CA.

As the Senior Design Quality Engineer, you will be actively involved in Product Risk Management, Post Market Surveillance, Design Control and Product Quality Improvement. You will be involved in a fast-paced mix of short design change efforts and will be responsible for product risk management and adherence to design control requirements throughout the product lifecycle. You will be responsible for ensuring that post market data and feedback is channeled into the risk management system throughout the product lifecycle. You will make regular use of problem-solving tools and statistical analysis to analyze and trend data and provide quality input into technical investigations, perform test method development and validation, design verification, risk assessment and design reviews. You will be responsible for supporting product testing and failure analysis, writing protocols and reports, creating and maintaining risk files and assessing the impact of necessary changes to our products. You will lead initiatives to increase sales and improve the customer experience of our devices.

Neurovascular (NV) products push the boundaries of technology to meet ever increasing product performance requirements, making the goal of assessing and demonstrating, safety, performance and compliance an exciting challenge.

What You Will Do

• Develop qualification plans, protocols, and reports for new products, existing products, components, and subassemblies.
• Execute product testing, inspection, verification, and validation activities to support design and quality objectives.
• Perform failure investigations and root cause analyses to identify product and process improvement opportunities.
• Create, maintain, and update product risk management documentation throughout the product lifecycle.
• Conduct risk assessments and support design reviews in accordance with applicable quality system and design control requirements.
• Apply statistical methods and problem-solving tools to support test method development, validation activities, and engineering investigations.
• Analyze specifications, test results, and process data, and recommend revisions to improve product quality and performance.
• Collaborate with engineering, regulatory, manufacturing, and quality teams to support product development, design changes, and compliance activities.

Required

• Bachelor’s degree in Engineering or a related technical discipline.
• Minimum 2 years of experience in engineering, quality engineering, manufacturing engineering, or a related technical role.
• Experience using structured problem-solving methodologies and quality improvement tools.
• Experience supporting product testing, validation, verification, risk management, or process improvement activities.

Preferred

• Experience in the medical device, healthcare technology, or other regulated industry.
• Knowledge of design controls, risk management, and quality system requirements.
• Experience with statistical analysis, test method development, and validation activities.
• Experience supporting new product introduction and product lifecycle management programs.
• US30: $101,000 - $168,400 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.