Design Quality Engineer II

Job Title:

Design Quality Engineer IIJob Description

We are seeking a Design Quality Engineer II to join our team for a project running through February 2027. The role involves developing quality assurance documentation to support new product development and regulatory submissions, maintaining the quality system for design control processes, and engaging in design, development, manufacturing, and risk management activities.

Responsibilities

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

* Support quality system maintenance for the design control process by identifying and correcting deficiencies.

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

* Participate in design reviews by identifying risks and tracking mitigation measures throughout the development process.

* Support the definition of design verification and validation test requirements.

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

* Promote efficient testing practices.

* Support Advanced Operations in developing manufacturing processes for new products.

* Utilize standard statistical analysis and problem-solving techniques for product acceptance limits and quality problem resolution.

* Develop, review, and approve inspection plans, routers, and product drawings for new products.

* Support product design transfers to internal and/or external manufacturing facilities.

* Evaluate predicate products for quality issues that may impact new product development projects.

* Analyze and define critical quality attributes for product and process through risk analysis techniques.

* Participate in initial market feedback collection on new products and address early concerns.

* Lead risk management activities by developing risk management plans and reports.

Essential Skills

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

* Applied knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.

* Ability to read and interpret CAD drawings.

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

* Thorough knowledge of US and International Medical Device Regulations.

* Strong knowledge of Quality Concepts (e.g., CAPA, Audits, Statistics).

* Strong project management skills and ability to manage multiple tasks simultaneously.

* Ability to advocate for product excellence and quality.

* Effective cross-functional collaboration skills with departments like Advanced Operations, Product Development, Regulatory Affairs, and Marketing.

* Strong interpersonal, written, oral communication, and negotiation skills.

* Critical thinking and "outside the box" thinking.

* Highly developed problem-solving skills and strong analytical skills.

* Ability to manage and complete projects in a matrix organization.

* Ability to work independently.

* Experience in compliance risk situations.

* Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Additional

Skills & Qualifications

* Experience in working in a compliance risk situation.

Work Environment

This position offers 3 weeks of PTO and 10 paid holidays. The work environment involves collaboration with various departments such as Advanced Operations and Product Development, and requires compliance with US and International Medical Device Regulations. The team values strong communication and analytical skills and encourages innovative and independent work.

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $55.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan -…