Design Quality Engineer I

Company : Kasmo Inc

Job Title: Design Quality Engineer I
Duration: 1+ Year Contract

Job Description

We are seeking a detail-oriented and proactive Design Quality Engineer I to join our team in Irvine, CA. This position plays a critical role in supporting new product development (NPD) activities by ensuring design control processes are robust, compliant, and well-documented. The ideal candidate will work cross-functionally with engineering, manufacturing, regulatory, and operations teams to ensure product quality and regulatory readiness throughout the product development lifecycle.

Key Responsibilities

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

• Ensure compliance by identifying and correcting deficiencies in design control procedures and practices.

• Participate in cross-functional design, development, manufacturing, and risk management activities.

• Define design verification and validation (V&V) test requirements and prepare statistically valid test protocols and reports.

• Support Advanced Operations in the development of manufacturing processes for new products.

• Apply risk analysis tools (e.g., FMEA) to define critical quality attributes and track mitigation activities.

• Assist in design reviews, evaluating quality-related risks and ensuring corrective actions are implemented.

• Review and approve inspection plans, engineering drawings, routers, and manufacturing documentation.

• Support design transfer activities to ensure smooth transition from R&D to production.

• Evaluate predicate devices and historical quality data to inform product development strategy.

• Lead and document risk management activities, including plans and reviews.

• Monitor and collect early field performance and customer feedback for continuous improvement.

Required Qualifications

• Bachelor's degree in Engineering or related field.

• 2–5 years of experience in medical device product development.

• Solid understanding of Design Control, Risk Management, and Design/Process V&V in a regulated environment.

• Hands-on experience with Advanced Quality tools: FMEA, Root Cause Analysis, Mistake Proofing (Poke Yoke), and GD&T.

• Familiarity with FDA, ISO 13485, and international medical device regulations.

• Ability to read and interpret CAD drawings.

• Strong communication, project management, and interpersonal skills.

• Proficiency with statistical tools such as Minitab or equivalent.

Preferred Skills

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

• Background in CAPA, audit readiness, and compliance risk evaluation.

• Ability to thrive in a matrixed environment and work independently with minimal supervision.

• Strong analytical and problem-solving mindset.

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