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Job Title: Design Quality Engineer IJob Description

This role involves developing quality assurance documentation to support the new product development process and regulatory submissions. You will maintain the quality system for the design control process by identifying and correcting deficiencies in procedures and practices. The position requires engagement in the design, development, manufacturing, and risk management activities for new product development projects, as well as participation in design reviews to identify risks and track mitigation strategies.

Responsibilities

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

+ Maintain quality systems for the design control process by identifying and correcting procedural deficiencies.

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

+ Participate in design reviews, identifying risks and tracking mitigation throughout the development process.

+ Define design verification and validation test requirements to ensure objective evidence supports acceptance criteria.

+ Complete final design verification and validation reports with statistically valid conclusions and graphical support.

+ Promote efficient testing practices and support Advanced Operations in developing manufacturing processes.

+ 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 for new products.

+ Support product design transfers to internal and/or external manufacturing facilities.

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

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

+ Participate in collecting initial market feedback on new products and address early concerns.

+ Lead risk management activities for new product development teams, conducting reviews and verifying implementation.

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 of US and International Medical Device Regulations.

+ Strong knowledge of quality concepts (e.g., CAPA, Audits, Statistics).

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

+ Demonstrated ability to advocate for product excellence and quality.

+ Effective cross-functional collaboration skills with departments like Advanced Operations, Product Development, Regulatory Affairs, and Marketing.

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

+ Critical thinking and 'outside the box' thinking skills.

+ Highly developed problem-solving and analytical skills.

+ Ability to manage and complete projects in a matrix organization.

+ Ability to work independently.

+ Experience in compliance risk situations.

+ Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Additional Skills & Qualifications

+ Experience with medical device product development lifecycle.

+ Demonstrated applied knowledge of Advanced Quality tools.

+ Strong project management skills.

+ Ability to advocate for product excellence and quality.

Work Environment

The work environment involves engaging with medical devices, emphasizing risk management and usability. Employees enjoy 2 weeks of PTO, 20 paid holidays, and standard benefits. The role requires interaction with regulatory agencies and adherence to US and International Medical Device Regulations.

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 Jun 13, 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.