Design Quality Engineer 2
Smith+Nephew
Summary
Join our Quality team in Austin and help bring safe, reliable medical device innovations to life. As a Quality Engineer, you will be a key quality partner for new product development, working across functions to ensure products meet demanding quality, safety, performance and regulatory requirements.
Job description
What will you be doing?
- Provide quality leadership for new product development project teams, serving as the Quality Engineering representative and partnering with cross functional teams.
- Generate, approve and manage design verification, design validation, sterilization validation, process validation, supplier qualification and test method activities.
- Develop protocols, capability studies and risk assessments to support product safety, reliability and overall risk management.
- Ensure compliance with applicable product standards and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN and EU MDR requirements.
- Support manufacturing operations with expertise in product requirements, inspection and test methods, root cause investigations and issue resolution.
- Partner with external laboratories and suppliers to communicate product and process requirements and assess capabilities.
- Support continuous improvement and compliance activities, including CAPA resolution and nonconformance investigations.
- Support Post Market Surveillance, Quality Management Reviews and internal and external audits or inspections.
What will you need to be successful?
- A 4-year technical degree is required, a bachelor's degree in biomedical or mechanical engineering is highly preferred
- 2-5 years in the medical device industry
- Familiarity with process development and new product development is a plus.
- Experience with design verification and validation, process or sterilization validation, risk management, test methods, supplier qualification and investigation or CAPA activities.
- Working knowledge of relevant medical device regulations and standards, including US FDA, QSR, cGMP, ISO and EU MDR requirements
Requirements
- 4-year technical degree required
- Bachelor's degree in biomedical or mechanical engineering highly preferred
- 2-5 years in the medical device industry
- Familiarity with process development and new product development is a plus
- Experience with design verification and validation
- Experience with process or sterilization validation
- Experience with risk management
- Experience with test methods
- Experience with supplier qualification
- Experience with investigation or CAPA activities
- Working knowledge of US FDA, QSR, cGMP, ISO and EU MDR requirements
Benefits
- 401(k) Matching
- 401(k) Plus Program
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Flexible PTO
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental & Vision
- Health Savings Account
- Employee Assistance Program
- Parental Leave
- Fertility & Adoption Assistance
- Fitness Club Discounts
- Hybrid Work Model
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.