Staff Design Quality Engineer (Memphis, TN)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Staff Design Quality Engineer serves as a key resource for design control, standards and regulation requirements within NPD and product support programs. Additionally, the role combines the needs of the customer, quality system, design control and operational success to support the S+N purpose to take the limits off living. The Staff Design Quality Engineer implements, supports and sustains elements of the Smith+Nephew Quality System through product and procedure generation and revision, risk management, creative problem solving and collaborating cross-functionally in a fast-paced, technical environment.

**This position does not offer visa sponsorship now or in the future**

What will you be doing?

• Provide quality leadership to project teams as the quality engineering representative, primarily for Trauma and Extremities programs involving risk management, design and development support, manufacturing quality support (internal and externally manufactured)

• Work with a cross-functional team to develop methods and procedures to ensure that the appropriate designs, critical to process and critical to function features are tested and challenged to ensure that product design and processes meet the required specifications/standards and that the safety and reliability of products are established.

• Contribute/review/approve design and process verifications and validations, supplier qualifications and capabilities, test and measurement methods, capability studies, and risk management documentation.

• Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.

• Ensure compliance to product specific standards, including, but not limited to cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD, and MDR requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.

• Work with outside suppliers, testing houses and labs to communicate Smith & Nephew product/process requirements as well as assess capabilities commensurate with needs.

• Support continuous improvement activities including CAPA/NC/Internal Audit, etc.

• Support Post Market Surveillance activities, Management Review, and audits/inspections as required

• Mentors and provides thought leading guidance to cross-functional business partners and other quality engineers related to quality and new product development

What will you need to be successful?

• Education: Bachelor's degree in engineering (Masters' or advanced degree preferred)

• Experience:

  • Bachelor's degree with 8+ years in the medical device or regulated industry is required.

  • Master's degree with 6+ years in the medical device or regulated industry is required.

  • Adaptability / Proficiency working within multiple PLM systems (Windchill, Smartsolve, similar eQMS and PLM system experience)

  • Prior successful medical device development and launch track record

• Leadership if any:

  • Experience mentoring quality engineers

  • Experience as a team/project leader within cross functional matrixed environment

• Travel Requirements:

  • <10% travel

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion and Belonging-Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more aboutEmployee Inclusion Groupson our website (https://www.smith-nephew.com/).

Life at Smith+Nephew: At Smith+Nephew, we care for one another professionally and personally. Find out more about inclusion, diversity and equity, flexibility, and wellbeing at work.

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.