Senior Design Quality Engineer (Hybrid)

Posted One Month Ago
Be an Early Applicant
2 Locations
Hybrid
101K-168K Annually
Senior level
Healthtech
The Role
Leads design quality activities for neurovascular medical devices, including product risk management, design controls, post-market surveillance, testing, validation, verification, failure investigations, statistical analysis, and quality improvement. Develops qualification plans, protocols, reports, and risk documentation while collaborating with engineering, regulatory, manufacturing, and quality teams throughout the product lifecycle.
Summary Generated by Built In
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 or Salt Lake City, UT.


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.

  



  • US5: $81,600.00 - $136,000.00 USD Annual
  • 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.

Skills Required

  • Bachelor's degree in Engineering or a related technical discipline
  • At least 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
  • Experience in medical devices, healthcare technology, or another 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

Inari Medical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.

  • Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
  • Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
  • Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.

Inari Medical Insights

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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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