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.
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.