Sr Staff Design Quality Engineer

Sr. Staff Design Quality Engineer Flower Mound Texas

Youll partner with product development teams to deliver design quality for complex electromechanical medical devices and consumables. This role focuses on translating user needs into design requirements guiding risk and test strategies and ensuring design documentation and verification align with global medical device standards. You lead technical problem solving mentor others and collaborate across functions to advance products through design development and launch.

You will support the Urology portfolio including legacy products and a recently launched product integrating capital equipment visualization platforms and fluid management technologies.

What you will do

• Lead design quality activities for electrical components subsystems and system-level designs on complex electromechanical medical devices and consumables.

• Support products in the midst of launch and postmarket stabilization navigating evolving priorities while maintaining design control rigor and riskbased decision making.

• Translate user needs into design inputs/specifications and maintain traceability through design outputs verification and validation deliverables.

• Define and execute advanced prototyping test methods and verification strategies aligned to applicable standards (e.g. IEC 60601 IEC 62304) and project plans.

• Identify and resolve complex product design issues by driving root cause investigations design tradeoff decisions and design changes with documented rationale.

• Create and refine regulated design documentation (including Design History File content) and mentor teams on good documentation practices and required technical evidence.

• Apply and coach risk management corrective and preventive action audit readiness and statistical methods within design and development activities.

• Partner with cross-functional stakeholders (Quality Manufacturing Regulatory Clinical Marketing and Project Management) to plan and deliver design reviews milestones and release readiness.

• Support direct customer and surgeon engagement including voiceofcustomer activities field feedback and quality events or complaints tied to design or usability translating realworld use into design improvements.

What you will need

Required

• Bachelors degree in Science Engineering or a related discipline.

• Minimum 6 years of experience in medical device product development and/or design quality engineering.

• Experience working within highly regulated industries with formal quality systems and design documentation practices (e.g. ISO 13485 or comparable industry standards).

• Experience with design controls risk management and verification/validation planning for electromechanical products.

Preferred

• A masters degree in a relevant discipline and certifications such as Certified Quality Engineer (CQE) Certified Reliability Engineer (CRE) or Six Sigma Green or Black Belt

• Experience supporting new product launches and postmarket design improvements for complex electromechanical medical devices and consumables

• Experience with medical device design and software lifecycle standards (e.g. IEC 60601 IEC 62304).

• Handson experience evaluating and testing:

  • Software code (C C C#)

  • Electronic designs including printed circuit board assemblies and subsystems

  • Mechanical designs and technical drawings

US10: $129800 - $216400 USD Annual

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