Design Quality Engineer II

Design Quality Engineer II

Location: Irvine, CA

Pay Rate: $55-$65/hr ($115,000-$130,000) Industry: Global Medical Technology & Innovation

About Us

Join a world-class leader in medical technology that is transforming healthcare through innovation and precision engineering. Their mission is simple yet powerful: to improve patient outcomes and empower healthcare professionals with cutting-edge solutions. They thrive on collaboration, integrity, and a relentless commitment to quality. There, your work will directly impact lives around the globe.

The Role

As a Design Quality Engineer II, for Actalent Services LLC, you will play a pivotal role in ensuring the quality and compliance of new medical device products throughout their development lifecycle. You'll support design control processes, lead risk management activities, and participate in design reviews to guarantee product excellence and adherence to global regulatory standards.

What You'll Do

• 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.

What We're Looking For

• 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.

Why You'll Love It Here

Work on life-changing technologies that make a real difference in healthcare. Collaborate in a dynamic, cross-functional environment focused on innovation and quality. Enjoy competitive benefits, including 3 weeks PTO and 10 paid holidays. Be part of a culture that values diversity, inclusion, and professional growth.

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 – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine, CA.

Application Deadline

This position is anticipated to close on Dec 23, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.