Research and Development Engineer II
Apply NowCompany: Compunnel Software Group
Location: Irvine, CA 92620
Description:
Job Description:
The NPD Quality Engineer will leverage expertise in quality engineering principles and methods to ensure compliance with regulatory requirements and optimize product design, internal and external device manufacturing, and device distribution. This role also involves coordinating and performing complaint investigations and managing DMR/DHR changes to support clinical inventory.
Key Responsibilities:
" Provide expertise in Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs.
" Investigate and resolve complex manufacturing product quality and compliance issues reported from the field, analyzing root cause/probable cause and initiating reports.
" Coordinate and execute change control activities to drive innovation.
" Support design and development activities, including engineering studies, feasibility testing, and drawing reviews.
" Participate in escalation tasks and activities, including Project Risk Assessments (PRA).
" Lead or support test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs.
" Collaborate with R&D and Manufacturing teams to ensure the successful execution of the NPD process and the launch of robust products.
" Develop and execute complex experiments and tests to validate products and manufacturing processes, and provide recommendations based on results.
" Develop, update, and maintain technical risk management files.
" Create training materials and documentation (e.g., work instructions) to facilitate seamless knowledge transfer of processes to production teams.
" Assign and oversee manufacturing support tasks, instruct and train technicians, and provide feedback while coordinating their activities.
" Perform other tasks assigned by Leadership.
" Travel up to 10% domestically and internationally.
Required Qualifications:
" Bachelor's degree in Engineering with at least 4 years of experience in NPD, Quality Engineering, R&D, and/or Manufacturing, OR a master's degree in Engineering or a Scientific field with relevant internship, senior project, or thesis experience.
" Proven engineering experience in a highly regulated industry.
Preferred Qualifications:
" Experience in the medical device field, including cardiovascular, endovascular, or critical care/surgical products, healthcare, or related areas.
" Proficiency in Design Assurance principles, including Design Controls, Verification & Validation, Test Method Development, and Process Validation.
" Experience conducting root cause analyses or investigations for Complaints, NCRs, or CAPAs.
" New Product Development experience from concept to commercialization (Class III preferred).
" Experience in Risk Management and Design Control processes.
" Proficiency with Microsoft Office Suite (Excel, PowerPoint, WordProject) and Adobe Acrobat.
" Basic understanding of statistical techniques.
" Strong problem-solving, organizational, analytical, and critical thinking abilities.
" Proven ability to manage projects and deliverables across multiple stakeholders.
" Excellent communication skills with cross-functional teams and leadership levels.
Education: Bachelors Degree
The NPD Quality Engineer will leverage expertise in quality engineering principles and methods to ensure compliance with regulatory requirements and optimize product design, internal and external device manufacturing, and device distribution. This role also involves coordinating and performing complaint investigations and managing DMR/DHR changes to support clinical inventory.
Key Responsibilities:
" Provide expertise in Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs.
" Investigate and resolve complex manufacturing product quality and compliance issues reported from the field, analyzing root cause/probable cause and initiating reports.
" Coordinate and execute change control activities to drive innovation.
" Support design and development activities, including engineering studies, feasibility testing, and drawing reviews.
" Participate in escalation tasks and activities, including Project Risk Assessments (PRA).
" Lead or support test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs.
" Collaborate with R&D and Manufacturing teams to ensure the successful execution of the NPD process and the launch of robust products.
" Develop and execute complex experiments and tests to validate products and manufacturing processes, and provide recommendations based on results.
" Develop, update, and maintain technical risk management files.
" Create training materials and documentation (e.g., work instructions) to facilitate seamless knowledge transfer of processes to production teams.
" Assign and oversee manufacturing support tasks, instruct and train technicians, and provide feedback while coordinating their activities.
" Perform other tasks assigned by Leadership.
" Travel up to 10% domestically and internationally.
Required Qualifications:
" Bachelor's degree in Engineering with at least 4 years of experience in NPD, Quality Engineering, R&D, and/or Manufacturing, OR a master's degree in Engineering or a Scientific field with relevant internship, senior project, or thesis experience.
" Proven engineering experience in a highly regulated industry.
Preferred Qualifications:
" Experience in the medical device field, including cardiovascular, endovascular, or critical care/surgical products, healthcare, or related areas.
" Proficiency in Design Assurance principles, including Design Controls, Verification & Validation, Test Method Development, and Process Validation.
" Experience conducting root cause analyses or investigations for Complaints, NCRs, or CAPAs.
" New Product Development experience from concept to commercialization (Class III preferred).
" Experience in Risk Management and Design Control processes.
" Proficiency with Microsoft Office Suite (Excel, PowerPoint, WordProject) and Adobe Acrobat.
" Basic understanding of statistical techniques.
" Strong problem-solving, organizational, analytical, and critical thinking abilities.
" Proven ability to manage projects and deliverables across multiple stakeholders.
" Excellent communication skills with cross-functional teams and leadership levels.
Education: Bachelors Degree