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Staff Advanced Quality Engineer (Hybrid)

Company: Stryker
Location: Flower Mound
Posted on: March 18, 2023

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: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-teamWe 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.comOur benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities.
Stryker is hiring a Staff Advanced Quality Engineer (Hybrid) in the Dallas, TX, area to join our Communications Infrastructure Quality Assurance team!You will focus on new product development for our surgical light, surgical table, and boom portfolios (the immediate need is for you to support surgical lights). Our cross-functional new product development teams operate globally across 3 sites in Flower Mound, Texas, Tuttlingen, Germany, and Gurgaon, India.We are passionate about driving innovation and working with our customers to improve healthcare through high-quality product releases! This role will have the opportunity to engage with customers in the operating room setting to understand customer needs and challenges so that they can effectively drive patient safety and surgical workflow efficiency solutions to our customers through new product releases.Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3-4 days onsite.Who we want:

  • Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to design medical devices.
  • User-focused creators. Engineers who design with the user in mind, developing medical devices that help change patients' lives.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.What you will do:
    • Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects.
    • Lead risk management activities to ensure the highest level of product and process quality.
    • Develop quality assurance documentation to support new product development processes and regulatory submissions.
    • Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
    • Partner with cross-functional project teams to lead product and/or process design and development activities.
    • Lead risk management activities for new product development projects.
    • Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
    • Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process mitigate those issues throughout the development process.
    • Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
    • Partner with Advanced Operations in the development of manufacturing processes for new products.
    • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
    • Develop, review, and approve inspection plans, routers, and product drawings for new products.
    • Support product design transfers to internal and/or external manufacturing facilities.
    • Provide support and direction for other Quality Engineers.
    • Evaluate predicate products for relevant quality issues that may impact new product development projects.
    • Analyze and define critical quality attributes for product and process through risk analysis techniques.
    • Participate in collection of initial market feedback on new products and address early concerns.
    • Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.What you need:Required:
      • Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering discipline.
        • Minimum of 4+ years of experience within a regulated industry.Preferred:
          • MS, CQE, or CRE preferred.
          • Ability to influence and lead authors without direct authority.
          • Preferred experience with medical device product development lifecycle, including risk management and design/process verification and validation.
          • Thorough knowledge and understanding of US and International Medical Device Regulations.
          • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
          • Demonstrated ability to read and interpret CAD drawings.
          • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
          • Strong knowledge of Quality Concepts (e.g., CAPA, Audits, Statistics).
          • Must possess strong project management skills as well the ability to manage multiple tasks simultaneously.
          • Demonstrated ability to advocate for product excellence and quality.
          • Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
          • Strong interpersonal skills, written, oral communication, and negotiations skills.
          • Strong in critical thinking and "outside the box" thinking.
          • Highly developed problem-solving skills. Strong analytical skills.
          • Demonstrated ability to successfully manage and complete projects in a matrix organization.
          • Demonstrated ability to work independently.
          • Experience in working in a compliance risk situation.
          • Computer literacy (including proficiency with Mini-Tab or similar analysis program).Travel
            • Ability to travel 15%
              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 at https://careers.stryker.com/referrals/About StrykerStryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.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.com

Keywords: Stryker, Flower Mound , Staff Advanced Quality Engineer (Hybrid), Engineering , Flower Mound, Texas

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