Search for Design Quality Engineer roles in Irvine, CA for full-time positions, requiring experience in medical device development, with strong project management skills, and knowledge of FDA regulations.

Okay, I've searched for Design Quality Engineer roles in Irvine, CA for full-time positions, requiring experience in medical device development, strong project management skills, and knowledge of FDA regulations. I found 27 positions that match your criteria.

Design Quality Engineer

Irvine, CA

Full Time

Experience with medical device product development

Project Management

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The Design Quality Engineer I role is fundamentally focused on ensuring the integrity and compliance of new medical devices through rigorous quality assurance processes. This position is crucial for supporting the new product development cycle, which necessitates not only technical documentation but also the application of advanced quality tools and methodologies to uphold regulatory standards and safety protocols. The responsibilities entail active participation in design reviews and risk management activities, which highlights the need for the candidate to exercise critical thinking and proactive problem-solving. Success in this role is likely defined not just by the completion of tasks, but by the quality of output—the ability to advocate for product excellence and to foster cross-functional collaboration in a matrixed environment will be pivotal. The candidate will also face challenges such as navigating complex regulatory landscapes and addressing potential quality issues, making resilience and adaptability key attributes for success.

Company Analysis:

Lensa operates within a rapidly transforming space, focusing on revolutionizing the job search experience with advanced machine learning technologies. This innovative approach positions Lensa as both a disruptor and leader in the career platform arena, which informs the role of Design Quality Engineer I by underscoring the need for a high standard of quality in new product development related to medical devices. The company culture seems to prioritize innovation and responsiveness to market needs, which could foster an environment where continuous improvement and adaptability are valued. Within Actalent, as a subsidiary, this role is likely part of a broader initiative aiming to elevate engineering and science services to meet stringent industry standards. The expectation for visibility within leadership channels suggests that the Design Quality Engineer will play a critical role in not only product outcomes but also in shaping quality practices across the organization. This alignment with Lensa’s mission of progressive, technology-driven solutions will help set the foundation for the candidate's long-term success and personal growth within the company.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Tell me about a time when you had to advocate for product quality in a team setting. What challenges did you face?
Describe a situation where you identified a significant procedural deficiency. How did you approach resolving it?
Can you provide an example of a project where you employed statistical analysis to solve a quality issue?
How do you prioritize multiple projects or tasks when faced with tight deadlines?
What is your experience with Failure Modes Effect Analysis (FMEA) in product development?
How do you ensure compliance with FDA regulations when developing new medical devices?
Describe your approach to writing quality assurance documentation for regulatory submissions.
Imagine you are part of a design review and discover a potential risk in the product design. How would you communicate this to the team?
Suppose a new product has received initial market feedback indicating usability concerns. How would you address these feedback points in your testing process?
Why are you interested in working at Lensa, and how does this position align with your career goals?
In what ways do you think Lensa's innovative approach to job searching affects the quality assurance process in product development?
What specific qualities do you believe are essential for succeeding in a fully onsite role focused on medical devices?
How do you decide which quality metrics are most important for a new product development project?
What questions do you have about the team culture and collaboration style at Lensa?
How does your background prepared you to contribute to the innovative objectives of Actalent?

Job Details

Overview Company

Design Quality Engineer I

$50/h-$55/h

Lensa

16 days ago

Highlight

OnsiteFull-timeEntry

Summary

Actalent is seeking a Design Quality Engineer I to join their team in Irvine, CA. The role involves developing quality assurance documentation and maintaining quality systems for new product development and regulatory submissions.

About the Role

As a Design Quality Engineer I, you will develop quality assurance documentation, maintain quality systems, engage in design and risk management activities, participate in design reviews, and define verification and validation test requirements. You will also support manufacturing processes, utilize statistical analysis, and lead risk management activities.

About You

Required:

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.
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.

Preferred:

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.

Benefits

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)

Lensa

What if we could take the search out of job search? This is the question Lensa has been answering since launching in San Francisco, California in August 2016. Using machine learning, we instantly provide companies with candidates and match professionals with positions that fit their skills, goals, personalities, and needs. How does it work? Lensa applies complex algorithms that identify the skills needed to succeed on a given job. Candidates can play computer games that assess their work style, thus gaining insight into their strengths while unlocking career opportunities. The result: job search that puts people first while reducing the time and cost of talent acquisition.

Lensa passed 10 million job seeker registrations in 2019, making the com- pany one of the premier career platforms.

With teams in multiple U.S. locations and a 60-strong crew of developers and data scientists at its R & D headquarters in Europe, Lensa is working every day to share its transformative career technology with the world.

Irvine, CA