Senior Quality Engineer (Hybrid)

Stryker; Colorado; Hybrid; USD 101,000 - 168,000; Full time

Job summary

Stryker is hiring a Senior Design Quality Engineer to join our Neurovascular division. This hybrid/onsite role is based in Fremont, CA, and will focus on product risk management, post-market surveillance, and compliance with design controls throughout the lifecycle.

You will lead risk management, implement quality improvements, and collaborate across engineering, regulatory, manufacturing, and quality teams to ensure device safety and performance.

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 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.

Skills

Structured problem-solving

Quality engineering

Product risk management

Statistical analysis

Education

Bachelor's degree in Engineering or related technical discipline

Job description

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Senior Quality Engineer to join our Neurovascular division. This is a hybrid r ole 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.