Senior Quality Engineer (Hybrid)

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

Job summary

Stryker Corporation in Fremont, CA is hiring a Senior Quality Engineer to support the Neurovascular division in a hybrid/onsite capacity. You will lead product risk management, post-market surveillance, design controls, and quality improvement across the lifecycle of NV products.

You will develop qualification plans, perform tests and validation, conduct root cause analyses, and maintain risk documentation while collaborating with engineering, regulatory, and manufacturing teams to ensure

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Minimum 2 years in engineering, quality engineering, manufacturing engineering, or a related technical role.
• Experience using structured problem-solving methodologies and quality improvement tools.
• Knowledge of design controls, risk management, and quality system requirements.
• Experience with statistical analysis, test method development, and validation activities.

Responsibilities

• 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.
• Collaborate with engineering, regulatory, manufacturing, and quality teams to support product development, design changes, and compliance activities.

Skills

Root cause analysis

Statistical analysis

Risk management

Quality engineering

Problem solving

Education

Bachelor's degree in Engineering

Job description

Work Flexibility: Hybrid or Onsite 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. What You Need 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 Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.