Job Description

READ FIRST! HARD REQUIREMENTS/NON-NEGOTIABLES:

1. MUST have 7+ years of Design Quality Assurance Engineering experience in the  medical device industry
2. No H1B Visa Sponsorship
3. Must be able local to the Irvine, CA area, no relocation support
4. Must have a BS in Engineering, Physical Sciences or equivalent

IF YOU MEET ALL FOUR (4) REQUIREMENTS ABOVE, PLEASE CONTINUE BELOW:



About the Role:

We are seeking a skilled and experienced Senior Quality Engineer – Design Assurance to join our team. The ideal candidate will have a minimum of 7 years of quality engineering and design assurance experience in the medical device industry. This role is critical to ensuring the performance, reliability, and sustainability of all devices manufactured by our Client.

Essential Duties and Responsibilities:

• Fulfill design assurance role on new product development (conception to launch) and sustaining projects.
• Complete planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
• Continued support and optimization of DA centric New Product Development deliverables and processes.
• Participate and lead New Product Development Phase Reviews and Design Reviews.
• Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
• Create and support the development and validation of new test methods.
• Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Develop the strategy and manage the execution of design verification and validation.
• Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
• Develop, execute, and manage First Article inspections.
• Provide direction to design assurance engineering technicians supporting assigned projects.
• Support improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
• Support regulatory approvals and responses to regulatory questions.
• Support Sustaining Engineering for design and process changes to commercialized product.
• Support the transfer of new product development projects from development to production.
• Support internal and external audits.

Note: 50% of this job involves direct R&D activities.

Education and/or Work Experience Requirements:

• Bachelor's degree in Engineering or Physical Sciences is required.
• 7+ years of experience in the medical device industry.
• Proficient in technical report writing and review.
• Experience with design controls, risk management, statistics, test method validation, and new product development processes.
• Experience with industry regulations such as ISO13485 and FDA QSR’s.

Additional Requirements:

• Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
• High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently.
• Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can-do” attitude and ability to work well under pressure.
• Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

Bonus Points:

• Prior startup or early-stage company experience.
• Familiarity with Microsoft Teams.

Physical Requirements:

• Must be able to lift up to 20 lbs.
• Must be able to work extended amounts of time standing or sitting based on projects and priorities.

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