Design Quality Engineer

Roles & Responsibilities:

Develop quality assurance documentation for new product development and regulatory submissions.

Maintain and improve quality system processes by identifying and correcting deficiencies.

Engage in design, development, manufacturing, and risk management activities for new projects.

Participate in design reviews, identify product risks, and ensure effective mitigation strategies.

Define and validate design verification and validation test requirements.

Complete final design verification and validation reports with statistical and graphical support.

Promote efficient testing practices and support manufacturing process development.

Utilize statistical analysis and problem-solving techniques to establish product acceptance limits.

Review and approve inspection plans, routers, and product drawings for new products.

Support product design transfers to manufacturing facilities.

Lead risk management activities, including developing risk management plans and conducting reviews.

Requirements:

Experience with medical device product development lifecycle, including risk management and design/process verification and validation.

Applied knowledge of advanced quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing).

Ability to read and interpret CAD drawings.

Experience interacting with regulatory agencies (FDA, MoH, TUV).

Thorough knowledge of US and international medical device regulations.

Strong understanding of quality concepts (CAPA, audits, statistics).

Excellent project management, communication, and problem-solving skills.

Proficiency with analysis programs like MiniTab.