Design Quality Engineer II

Job Title : Design Quality Engineer II

Location : Irvine, CA

Experience : 6+ Years

Duration : 12+ months contract

Job Summary

This role centers on making sure new medical device products meet the highest standards of quality, safety, and compliance from early design through final release. You'll guide design controls, drive risk management, support verification and validation, and work closely with cross-functional teams to keep development on track and aligned with regulatory expectations.

Responsibilities

Develop quality assurance documentation to support new product development and regulatory submissions

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

Contribute to design development manufacturing and risk management activities across NPD projects

Participate in design reviews identify product risks and ensure mitigation strategies are sound

Support creation of design verification and validation test requirements

Prepare final verification and validation reports including statistical and graphical analysis

Promote efficient testing methods and assist in developing manufacturing processes for new products

Use statistical tools and problem-solving methods to establish acceptance criteria and resolve quality issues

Develop review and approve inspection plans routers and product drawings for new designs

Support design transfer activities to manufacturing sites

Evaluate predicate products to identify quality issues relevant to new development

Define critical quality attributes through structured risk analysis

Gather and assess initial market feedback and address early concerns

Lead risk management efforts including developing risk plans and conducting risk reviews

Essential Skills

Hands-on experience with the medical device product development lifecycle

Strong knowledge of risk management and design / process verification and validation

Working knowledge of advanced quality tools FMEA GD&T RCA Mistake Proofing

Ability to read and interpret CAD drawings

Experience interacting with regulatory agencies including FDA MoH TUV

Knowledge of US and international medical device regulations

Familiarity with CAPA audits and statistical quality concepts

Solid project management capability and ability to juggle multiple priorities

Strong communication interpersonal and negotiation skills

Strong analytical critical thinking and independent problem-solving ability

Experience handling compliance and risk situations

Proficiency with analysis software such as Minitab

Additional Skills

Ability to advocate for product quality throughout the development process

Comfortable working cross-functionally with Operations R&D RA Marketing and others

Demonstrated success managing and completing projects within a matrix environment