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Design Quality Engineer IIPosition Overview

We are seeking an experienced Design Quality Engineer II to support a long-term new product development initiative extending through February 2027. This role plays a critical part in ensuring design quality, regulatory compliance, and risk management throughout the medical device product lifecycle. The ideal candidate brings a strong foundation in design controls, verification and validation, and cross‑functional collaboration within a regulated medical device environment.

This position partners closely with Product Development, Advanced Operations, Regulatory Affairs, Manufacturing, and Marketing to ensure products meet the highest standards of safety, performance, and quality from concept through commercialization.

About the Client You Will Support

You will be supporting a rapidly growing, innovation-driven medical device manufacturer focused on minimally invasive, life‑saving technologies. The organization is dedicated to improving patient outcomes through thoughtful design, rigorous engineering, and uncompromising quality standards. Operating in a highly regulated global environment, the company combines a fast-paced, entrepreneurial spirit with a deep commitment to clinical excellence, regulatory compliance, and continuous improvement.

The culture values technical rigor, collaboration, and accountability, empowering team members to influence key decisions and make a measurable impact on products that directly improve patient lives.

Key Responsibilities

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

+ Maintain and improve quality system processes related to design controls, identifying and correcting deficiencies

+ Actively engage in design, development, manufacturing, and risk management activities across multiple projects

+ Participate in design reviews, identifying risks and tracking mitigation actions throughout development

+ Support the definition of design verification and validation testing requirements

+ Complete final V&V reports with appropriate statistical analysis and graphical representation

+ Promote efficient, compliant, and risk‑based testing strategies

+ Partner with Advanced Operations to support development of scalable manufacturing processes

+ Apply statistical analysis and structured problem-solving techniques to define acceptance criteria and resolve quality issues

+ Develop, review, and approve inspection plans, routers, and engineering drawings

+ Support design transfer activities to internal and external manufacturing partners

+ Evaluate predicate devices to identify quality risks impacting new product development

+ Analyze and define critical quality attributes using formal risk analysis methodologies

+ Participate in early post‑launch market feedback activities and address initial quality concerns

+ Lead design and product risk management activities, including development of risk management plans and reports

Essential Qualifications

+ Experience across the medical device product development lifecycle, including design controls, risk management, and verification and validation

+ Applied knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing (Poka‑Yoke)

+ Ability to read and interpret engineering and CAD drawings

+ Experience interfacing with regulatory bodies (FDA, international ministries of health, notified bodies)

+ Thorough understanding of U.S. and international medical device regulations

+ Strong understanding of quality system principles including CAPA, audits, and statistical methods

+ Proven project management skills with the ability to manage multiple priorities in parallel

+ Ability to effectively advocate for product excellence and patient safety

+ Strong cross‑functional collaboration skills across engineering, operations, regulatory, and commercial teams

+ Excellent written, verbal, and interpersonal communication skills

+ Critical and creative problem‑solving capabilities

+ Ability to operate effectively within a matrixed organization

+ Comfortable working independently with minimal supervision

+ Proficiency with data analysis tools such as Minitab or equivalent

Additional Qualifications

+ Experience working in compliance risk or high‑visibility regulatory situations

+ Prior involvement supporting design transfer or commercialization activities

Work Environment & Benefits

+ Contract assignment through February 2027

+ 3 weeks of paid time off and 10 paid holidays

+ Highly collaborative, cross‑functional environment

+ Exposure to innovative, market‑leading medical device technologies

+ Emphasis on analytical thinking, accountability, and continuous improvement

+ Encouragement of independent thought and proactive problem-solving

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 Jan 21, 2026.

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.