Design Quality Engineer II

Design Quality Engineer II

We are seeking a dedicated Design Quality Engineer II to play a pivotal role in developing quality assurance documentation for new product development and regulatory submissions. This position involves maintaining quality systems for design control processes, engaging in product development activities, and supporting the design verification and validation processes.

Responsibilities

• Develop quality assurance documentation to support new product development and regulatory submissions.
• Maintain quality systems for design control processes by identifying and addressing procedural deficiencies.
• Engage in the design, development, manufacturing, and risk management activities for new product development projects.
• Participate in design reviews by identifying risks and tracking mitigation through design, documentation, and manufacturing processes.
• Define and support design verification and validation test requirements to ensure objective evidence meets acceptance criteria.
• Complete final design verification and validation reports with statistical and graphical support.
• Promote efficient testing practices.
• Support Advanced Operations in developing manufacturing processes for new products.
• Utilize statistical analysis and problem-solving techniques to determine product acceptance limits and resolve quality issues.
• Develop, review, and approve inspection plans, routers, and product drawings.
• Support product design transfers to manufacturing facilities.
• Evaluate predicate products for quality issues impacting new product development.
• Analyze and define critical quality attributes through risk analysis.
• Participate in collecting initial market feedback on new products and address early concerns.
• Lead risk management activities by developing plans and reports, conducting reviews, and verifying implementation effectiveness.

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 like FDA, MoH, TUV.
• Thorough understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics.
• Project management skills and ability to manage multiple tasks simultaneously.
• Advocacy for product excellence and quality.
• Ability to work cross-functionally with departments like Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
• Strong interpersonal, written, oral communication, and negotiation skills.
• Critical and analytical thinking skills.
• Problem-solving skills and ability to work independently.
• Experience in compliance risk situations.
• Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Additional Skills & Qualifications

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

Work Environment

This role offers 3 weeks of PTO and 10 paid holidays. The position involves working with advanced technology and equipment in the medical device industry, adhering to quality standards and regulations. The work environment is collaborative, cross-functional, and focused on innovation and quality excellence.

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 12, 2026.