Sr. Design Quality Engineer

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

Reporting into the Quality Department, this role has responsibility for supporting new product development (NPD)activities for Arthroscopic Enabling Technologies products as a lead Design Quality Engineer. 

Areas of focus for this position include digital imaging acquisition and processing, computer vision, machine learning, artificial intelligence, video streaming, server connectivity, and hospital information systems.

The individual will support the completion of Design Control and Risk Management requirements and help to ensure that the finished devices will be safe and effective and conform to applicable regulatory requirements.

Provide guidance/instruction to more junior engineers while working collaboratively to support active NPD programs.

What will you be doing?

• Supports new product development to deliver safe and effective products to the market by ensuring all aspects of design controls are robust and comply with company polices and governmental regulations. Key design control deliverables include but are not limited to: Software deliverables, risk management, product performance analysis on similar products, design verification / validation, design transfer to manufacturing, DHF tracking and completion, and product release authorization for distribution.

• Subject matter expert for technical design reviews, including SW code reviews - responsible for compiling and presenting the quality data to key stakeholders/ leadership during technical design reviews.

• Assist in preparation for regulatory submissions and provide support during audits and inspections. 

• Works cross-functionally to influence key stakeholders. Trains and provides guidance to quality engineers on design control, software quality, and print interpretation/reviews, provides training, provides leadership and mentorship to teams and junior QEs.

• Lead or assist in process improvement and CAPA, utilizing tools such as six sigma or lean manufacturing. Researches and provides insight into current trends in design control and risk management, following new standards and regulations. Lead design control gap assessments and remediation as required.

What will you need to be successful?

• Education: Minimum BS in engineering or a technically related field. MS preferred.

• Experience:

  • 3-5 years of relevant experience

  • Considerable hands-on experience in Medical Device Design Controls and/or Quality Systems with strong working knowledge of FDA QSR and ISO 13485 preferred.

  • Risk Management per ISO 14971

  • Medical device software development per IEC 62304 preferred

  • Background in machine learning, digital image processing, AI, or computer vision preferred.

• Travel Requirements: up to 10%

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

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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.