Sr. Biomedical R&D Quality Engineer

This range is provided by Infosoft, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$63.05/hr - $63.05/hr

Job Title:

Sr. Biomedical R&D Quality Engineer

Pay Rate: $50 to $63.05/HR

Duration: 6 months

Location:

Irvine, CA

Shift: 8am to 5pm

We are looking for Sr. Biomedical R&D Quality Engineer

This Sr. Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory.

• Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs.
• Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Coordinate and execute change control activities to support rapid innovation.
• Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.).
• Participate in escalation tasks and activities, including Project Risk Assessments (PRA).
• Support or lead test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs.
• Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launch of robust products.
• Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports.
• Ability to travel up to 10% domestically and internationally.

What you’ll need (Required Qualifications):

• Bachelor’s degree in Engineering with a minimum of (4) years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a master’s degree in engineering or Scientific field with internship, senior projects, or thesis experience required.
• Engineering experience within a highly regulated industry.

What else do we look for (Preferred Qualifications):

• Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment is preferred.
• Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation.
• Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
• New Product Development experience from initial concept to commercialization (Class III preferred).
• Experience with Risk Management and Design Control.
• Proven expertise in usage of MS Office Suite including MS Excel, Power Point, and Word.
• Experience with using Adobe Acrobat.
• Basic understanding of statistical techniques.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Self-project management and tracking of deliverables with various participants and stakeholders.
• Strong communication skills across various cross-functional groups and levels.

Mid-Senior level

Contract

Medical Equipment Manufacturing and Manufacturing