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Job Title: Design Quality Engineer IIJob Description

As a Design Quality Engineer II, you will play a crucial role in ensuring the quality and compliance of new medical device products throughout their development lifecycle. You will be responsible for supporting the design control process, conducting risk management activities, and engaging in design reviews to ensure product excellence and adherence to regulatory standards.

Responsibilities

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

+ Maintain quality system processes by identifying and correcting deficiencies in procedures and practices.

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

+ Participate in design reviews by identifying product risks and ensuring effective mitigation strategies.

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

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

+ Promote efficient testing practices and support the development of manufacturing processes for new products.

+ Utilize statistical analysis and problem-solving techniques to establish product acceptance limits and resolve quality issues.

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

+ Support product design transfers to manufacturing facilities.

+ Evaluate predicate products for relevant quality issues impacting new development projects.

+ Analyze and define critical quality attributes through risk analysis techniques.

+ Participate in the collection of initial market feedback and address early concerns.

+ Lead risk management activities by developing risk management plans and conducting risk reviews.

Essential Skills

+ Experience with the 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.

+ Ability to read and interpret CAD drawings.

+ Experience interacting with regulatory agencies such as FDA, MoH, TUV.

+ Thorough knowledge of US and International Medical Device Regulations.

+ Strong knowledge of Quality Concepts like CAPA, Audits, Statistics.

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

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

+ Critical thinking and problem-solving skills.

+ Analytical skills and the ability to work independently.

+ Experience in compliance risk situations.

+ Proficiency with computer literacy, including analysis programs like Mini-Tab.

Additional Skills & Qualifications

+ Demonstrated ability to advocate for product excellence and quality.

+ Ability to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing.

+ Demonstrated ability to manage and complete projects in a matrix organization.

Work Environment

The role is embedded in a dynamic environment focusing on new product development within the medical device industry. Expect to collaborate with cross-functional teams, utilizing advanced quality tools and technologies. The position offers 2 weeks of PTO and 10 paid holidays. Enjoy a supportive work culture that values quality and innovation.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $50.00 - $55.00/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 1, 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 [email protected] (%[email protected]) for other accommodation options.