Senior NPI Quality Engineer

Location

Leesburg, VA | United States

Job description

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products.  You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team:  

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting 

Stryker is hiring a Senior NPI Quality Engineer (Hybrid) to support our regional NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities.

Workplace Flexibility: Candidate must reside within a commutable distance to Leesburg, Virginia but is expected to be onsite at the facility multiple times/week.

Who we want –

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Business-oriented evaluators . People who effectively interpret information to demonstrate the effects of business initiatives and industry trends for sales, management and leadership teams.
• Analytical problem solvers . People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

What you will do:

• Lead technical quality assurance efforts throughout the product development lifecycle, emphasizing design for manufacture and assembly.
• Provide leadership in quality systems development, regulatory compliance, and process risk management, including pFMEA.
• Support the introduction of new products, processes, and technologies with a focus on scalability and high yield.
• Develop robust inspection strategies and lean inspection plans, optimizing efficiency while ensuring repeatability and scalability.
• Drive continuous improvement in inspection methods and sampling plans, minimizing human error risk.
• Oversee First Article Inspection (FAI) strategies and optimize inspection costs through lean initiatives.
• Develop and approve Measurement System Analysis (MSA) strategies.
• Support validation strategies to ensure highly capable processes with high yield and scalability.
• Apply statistical techniques to develop robust quality systems for production environments.
• Provide expertise in problem-solving, root cause analysis, and Design for Manufacture and Assembly (DFMA).
• Support supplier qualification and validation processes, ensuring highly capable and scalable processes.
• Influence supplier selection and support the implementation of supplier certification.
• Represent quality assurance during design transfer processes, ensuring product launches meet established metrics.
• Provide subject matter expertise in design transfer processes, procedures, and audits.
• Ensure integrity of process design through robust quality deliverables.
• Support device design into production specifications and post-launch quality process support.
• Implement appropriate system containment to prevent product escape during pre-released builds.

What you will need

Required :

• Bachelor degree required
• 2+ years’ experience working in a highly regulated environment in Quality, Research and development, process development or advanced operations with working knowledge in New product Introduction (NPI) and Supplier or Customer management

Preferred :

• Bachelor degree in a Science or Engineering preferred.
• Master of Science, Engineering with 2+ expertise in quality management within the realm of new product/process development.
• CQE or equivalent coursework/experience
• Familiarity with advanced product quality planning
• Proficient in understanding Med Device manufacturing processes
• Familiarity with ISO 13485, QSR, GDP, GMP
• Lean Six Sigma training
• Highly proficient in Validation, especially Computer System validation
• Competency in Metrology and interpreting engineering drawings
• Ability to generate, follow, and explain detailed operating procedures
• Experience in executing problem-solving techniques using lean six sigma tools
• Excellent analytical and interpersonal skills
• Working knowledge/experience of risk-based and statistical techniques
• Change management and continuous improvement mindset
• Ability to represent quality cross-functionally.

About Stryker

Our benefits:

• 12 paid holidays annually

• 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more:  US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at  stryker.com.

Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our  referral page

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.

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