Design Quality Engineer II

Job Title: Design Quality Engineer II

Job Description

We are seeking a Design Quality Engineer II who will be responsible for developing quality assurance documentation to support new product development processes and regulatory submissions. The ideal candidate will support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices. This role involves engaging in the design, development, manufacturing, and risk management activities for new product development projects.
Responsibilities

• Develop quality assurance documentation to support new product development process and regulatory submissions.
• Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
• Engage in the design, development, manufacturing, and risk management activities for new product development projects.
• Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Support the definition of design verification and validation test requirements to ensure appropriate objective evidence is available to support the acceptance criteria.
• Complete final design verification and validation reports with concise conclusions, statistical validity, and graphical support.
• Promote efficient testing practices.
• Support Advanced Operations in developing manufacturing processes for new products.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, and resolve quality problems.
• Develop, review, and approve inspection plans, routers, and product drawings for new products.
• Support product design transfers to internal and/or external manufacturing facilities.
• Evaluate predicate products for relevant quality issues that may impact new product development projects.
• Analyze and define critical quality attributes for product and process through risk analysis techniques.
• Participate in the collection of initial market feedback on new products and address early concerns.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying the implementation and effectiveness of risk controls.

Essential Skills

• Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
• Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
• Ability to read and interpret CAD drawings.
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Concepts (e.g., CAPA, Audits, Statistics).
• Strong project management skills and the ability to manage multiple tasks simultaneously.
• Ability to advocate for product excellence and quality.
• Ability to work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
• Strong interpersonal, written, oral communication, and negotiation skills.
• Strong in critical thinking and 'outside the box' thinking.
• Highly developed problem-solving skills and strong analytical skills.
• Ability to successfully manage and complete projects in a matrix organization.
• Ability to work independently.
• Experience working in a compliance risk situation.
• Computer literacy, including proficiency with Mini-Tab or similar analysis program.

Additional Skills & Qualifications

• Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
• Strong interpersonal, written, oral communication, and negotiation skills.
• Highly developed problem-solving skills.
• Strong analytical skills.
• Ability to work independently.
• Experience working in a compliance risk situation.

Work Environment

This position operates in an office and manufacturing setting. Standard work hours are 40 hours per week, Monday through Friday. Dress code is business casual. The role involves using various technologies and equipment, including computers with statistical analysis software.
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 Apr 30, 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.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.