Design Quality Engineer II

Position 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 ResponsibilitiesDevelop quality assurance documentation to support new product development and global regulatory submissionsMaintain and improve quality system processes related to design controls, identifying and correcting deficienciesActively engage in design, development, manufacturing, and risk management activities across multiple projectsParticipate in design reviews, identifying risks and tracking mitigation actions throughout developmentSupport the definition of design verification and validation testing requirementsComplete final V&V reports with appropriate statistical analysis and graphical representationPromote efficient, compliant, and risk‑based testing strategiesPartner with Advanced Operations to support development of scalable manufacturing processesApply statistical analysis and structured problem-solving techniques to define acceptance criteria and resolve quality issuesDevelop, review, and approve inspection plans, routers, and engineering drawingsSupport design transfer activities to internal and external manufacturing partnersEvaluate predicate devices to identify quality risks impacting new product developmentAnalyze and define critical quality attributes using formal risk analysis methodologiesParticipate in early post‑launch market feedback activities and address initial quality concernsLead design and product risk management activities, including development of risk management plans and reportsEssential QualificationsExperience across the medical device product development lifecycle, including design controls, risk management, and verification and validationApplied 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 drawingsExperience interfacing with regulatory bodies (FDA, international ministries of health, notified bodies)Thorough understanding of U.S. and international medical device regulationsStrong understanding of quality system principles including CAPA, audits, and statistical methodsProven project management skills with the ability to manage multiple priorities in parallelAbility to effectively advocate for product excellence and patient safetyStrong cross‑functional collaboration skills across engineering, operations, regulatory, and commercial teamsExcellent written, verbal, and interpersonal communication skillsCritical and creative problem‑solving capabilitiesAbility to operate effectively within a matrixed organizationComfortable working independently with minimal supervisionProficiency with data analysis tools such as Minitab or equivalentAdditional QualificationsExperience working in compliance risk or high‑visibility regulatory situationsPrior involvement supporting design transfer or commercialization activitiesWork Environment & BenefitsContract assignment through February 20273 weeks of paid time off and 10 paid holidaysHighly collaborative, cross‑functional environmentExposure to innovative, market‑leading medical device technologiesEmphasis on analytical thinking, accountability, and continuous improvementEncouragement of independent thought and proactive problem-solvingJob 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 Feb 4, 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 actalentaccommodation@actalentservices.com for other accommodation options.