Design Quality Engineer (South Austin, TX)

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

The Design Quality Engineer 1 will play a pivotal role by enabling the ENT New Product Development Team through quality leadership within the cross functional and ENT quality team. He/She serves as a key resource for design control, standards and regulation requirements within NPD and product support programs. The Design Quality Engineer 1 implements, supports and sustains elements of the Smith+Nephew Quality System through procedure generation, training, auditing and technical support.

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

What will you be doing?

• Provide quality leadership to project teams as the quality engineering representative.

• Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established.

• Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test 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, though 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 labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.

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

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

What will you need to be successful?

• Education: Bachelor’s degree in engineering

• Experience:

  • 0-2 years in the medical device or related industry

  • General / Basic Understanding of Design Control (FDA CFR 820, ISO 13485, EUMDR, GxP, etc)

  • Ability to manage multiple projects / tasks at a time

  • Ability to prioritize project tasks and deadlines

  • Demonstration of effective written / oral communication skills

  • Excel and Power BI proficiency

  • Statistical background (preferred) and software proficiency (i.e. Minitab)

  • Ability to be a team player

• Travel Requirements: <5%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

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

#LI-LS2

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.