Design Quality Engineer

The Bio-Rad Laboratories Design Quality Assurance team located in Irvine, CA, is seeking a detail oriented Design Quality Engineer to support the design, development and maintenance of life science and clinical diagnostics products.  You will work closely with local and global cross functional team members and play an essential role in ensuring design and development activities meet regulatory and quality requirements and support design control, risk management and product development activities throughout the products’ lifecycle.

How You'll Make An Impact:

• Collaborate with global cross-functional teams (R&D, Regulatory, Manufacturing, etc.) to ensure product development aligns with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, MDSAP, IVDR) and internal quality requirements. 
• Drive and maintain Design Control activities including Design History Files (DHF), Design Input/Output documentation, Verification and Validation plans and reports.
• Facilitate and support Risk Management activities per ISO 14971 and internal procedures, including creation and maintenance of risk documentation (plans, reports, FMEA, Hazard Analysis). 
• Provide quality oversight and guidance during the product development lifecycle, including design reviews, design changes, and process development.
• Support design verification and validation testing by reviewing protocols, reports, and ensuring traceability.
• Collaborate in the transfer of products from development to manufacturing, ensuring quality compliance.
• Participate in internal and external audits, including remediation activities when needed.
• Support CAPA investigations and change control processes related to design and development as needed.
• Stay current with industry standards, regulatory updates, and best practices relevant to IVD, research use only and software products.

What You Bring:

• B.S./B.A. (or equivalent) in a scientific or engineering discipline.
• 2+ years of experience (or an equivalent combination of education and experience). 
• Basic knowledge of and application of Quality Engineering and Risk Management principles required.
• Understanding of GMP/ISO regulations (ISO 14971, ISO 13485, IEC 62366, MDSAP, IVDR and FDA 820/210/211).
• Detail-oriented, excellent organization and project management skills.
• Strong critical thinking, leadership, and communication skills, with a collaborative attitude and an eagerness to make an impact in a dynamic environment.
• Experience in software development including IEC 62304 is a plus.
• SalesForce, SAP and Power BI experiences, Six Sigma Green or Black Belt certification is a plus.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well.  That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!  

Compensation: The estimated base salary range for this position is $84,300 - $116,000 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is also eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. 

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it. #LI-PB1