We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)

Stryker is seeking a Staff NPI Quality Engineer (Hybrid) to join our NPI QE team within the Global Quality Organization. In this role, you will collaborate with Advanced Operations and Design Assurance to ensure quality assurance throughout the design transfer process and across the entire product development lifecycle.

Work Flexibility: (Hybrid) – While this role offers a hybrid work arrangement, there is an expectation for 3-5 days of onsite work per week for essential cross-functional collaboration. The number of onsite days may vary depending on project and business needs, and the schedule remains flexible to accommodate both onsite and remote work requirements and is up to the discretion of the direct manager.

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.

• Self-directed initiators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do:

• Cross-Functional Collaboration: Lead and foster relationships across Design Divisions, Advanced Operations, and GQO functions to support design transfer activities. Ensure clear communication with internal customers, stakeholders, and project teams to deliver successful project transfers while meeting NPI project goals.

• Mentorship: Mentor cross-functional teams, emphasizing design and process transfer expertise.

• Risk Management: Apply advanced risk management practices (PFMEA) to evaluate process risks, ensure mitigation, and establish production controls. Maintain compliance with ISO14971 and support dFMEA and CQA/CTQ inputs.

• Inspection: Develop lean inspection strategies utilizing modern technologies. Lead continuous improvement efforts to enhance inspection methods and sampling plans, minimizing human error. Oversee and approve First Article Inspections (FAI) and implement efficient Measurement System Analysis (MSA) strategies.

• Validation: Support and approve validation strategies aimed at developing highly capable and scalable processes. Influence processes towards validation over manual verification and provide support for sterilization validation when needed.

• Process Excellence: Apply statistical techniques to establish robust, predictive quality systems. Serve as an expert on NCs and CAPAs, supporting DFMA through process design, inspection optimization, and human factor error prevention.

• Purchasing Controls: Contribute to supplier qualification and validation strategies, ensuring scalable processes and meeting Stryker’s standards. Influence supplier selection and certification, and establish Quality Agreements with suppliers.

• Design Transfer: Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process, ensuring product launches meet metrics such as Right First Time (RFT) and inspection costs. Support audits, design reviews, and the integrity of process design. Provide post-launch quality process support and ensure product containment during pre-release builds.

​ What you will need

Required :

• Bachelors degree required

• Minimum of 4+ years working in a highly regulated environment – medical device or pharmaceutical industry is strongly preferred

Preferred :

• Bachelor of Science or Engineering in the areas of Electrical, Mechanical or Electromechanical Engineering would be strongly preferred.

• Expertise in manufacturing and process design, with a strong focus on optimizing production workflows, improving efficiency, and ensuring quality control throughout the development lifecycle.

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.

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.