Sr. Biomedical R&D Quality Engineer

Infosoft, Inc.; Irvine (CA); On-site; USD 68,880 - 86,857; Full time

Job summary

An established industry player is seeking a skilled Sr. Biomedical R&D Quality Engineer to ensure compliance with quality engineering principles. In this dynamic role, you will support new product development, investigate complex quality issues, and collaborate with R&D and manufacturing teams to optimize product design and manufacturing processes. Your expertise will contribute to the success of innovative medical devices, making a significant impact in the healthcare sector. If you have a passion for quality engineering and thrive in a regulated environment, this opportunity is a perfect fit for you.

Qualifications

• 4+ years experience in NPD, Quality Engineering, R&D, or Manufacturing.
• Experience in a highly regulated industry is essential.

Responsibilities

• Support Quality Assurance and Design Controls for New Product Development.
• Investigate manufacturing product quality and compliance issues.

Skills

Quality Engineering

Problem-Solving

Statistical Techniques

Root Cause Analysis

Project Management

Communication Skills

Education

Bachelor's degree in Engineering

Master's degree in Engineering or Scientific field

Tools

MS Office Suite

Adobe Acrobat

Job description

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.

Base pay range

$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.

Responsibilities:

• 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.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Medical Equipment Manufacturing and Manufacturing