Senior Design Quality Engineer

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Stryker is hiring a Senior Quality Engineer in Flower Mound, Texas. In this role, you will partner closely with cross-functional New Product Development (NPD) teams to define design requirements and drive new product development. You will also oversee Design and User validation labs, ensuring the safety and reliability of new products. Additionally, you will lead risk management activities to ensure the highest level of product quality.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working multiple days onsite.

What You Will Do

• Responsible for quality of new products from concept to post launch.
• Participate in market feedback collections, on new products, addressing early concerns.
• Evaluate predicate products for potential quality issues impacting new development.
• Run Design and User validation labs, partner with cross-functional project teams to lead product and/or process design and development, testing and product transfer activities.
• Partner with project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
• Lead risk management activities for new products (risk assessments, track mitigation efforts, and evaluate residual risk).
• Analyze critical quality attributes for product and process through risk analysis techniques.
• Carry out additional clinically relevant testing to ensure the product is designed for quality and reliability.
• Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
  
  

What You Need

Required :

• BS in science, engineering or related discipline.
• 2 years related experience; Quality Assurance and/or R&D.
  
  

Preferred

• BS in Electrical Engineering, Computer Engineering
• Demonstrated electrical/mechanical problem-solving skills
• Previous Medical Device experience
• Previous Risk Management experienced
• Blueprint/engineering schematic reading and interpretation
• Working knowledge of data collection, data analysis, evaluation, and scientific method.
  
  

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.