Senior Design Quality Engineer
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.
Apply Now
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.
Apply Now