Staff Design Quality Engineer (Austin, TX)
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Job Description
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Staff Design Quality Engineer will play a pivotal role by providing quality leadership in the ENT New Product Development cross functional team. 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 procedure generation, training, auditing and technical support.
What will you be doing?
Provide quality leadership to project teams as the quality engineering representative, primarily for ENT programs involving electrical/electronic devices or components, as well as combination products including drugs and devices.
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: Minimum of Bachelor's degree in engineering
Experience:
Bachelor's degree with 8+ years in the medical device or regulated industry
Master's degree with 5+ years in the medical device or regulated industry
Adaptability / Proficiency working within multiple PLM systems (Agile, Arena, Smartsolve, Windchill)
Pharma experience preferred.
Pre-Market Approval (PMA) experienced preferred
Leadership if any:
Experience mentoring junior engineers
Experience as a team leader within cross functional team settings
No formal management experience required
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Training: Hands-On, Team-Customized, Mentorship
Extra Perks: Discounts on fitness clubs, travel and more
Travel Requirements:
You. Unlimited
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).
Other reasons why you will love it here!
Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day
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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.
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