Position : Engineer II (NPD) , Req# : 9875-1
Location : Irvine, CA (100% Onsite)
Duration : 6 Months Contract
Job Description :
What does your group do? New product development quality / design assurance
Does your team use any specific technology / software you want us to look out for? MS Office Suite
What will a typical workday look like? 8-hour day - Onsite full time.
What will the work schedule be? Can any overtime be expected? Standard office hours, Overtime available if issues arise that require the work.
What are your top technical skills
- Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs
- Supports or leads test method development / validation activities for Design Verification testing and manufacturing inspections for NPD programs
- Investigate complex manufacturing product quality issues reported from the field, analyze results, determine root cause / probable cause, and initiate and review reports.
- 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)
- Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching 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
- Develop, update, and maintain technical content of risk management files
Education and Experience :
Bachelor’s degree in the engineering field with a minimum of (2) 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 industryAdditional Skills :
Experience in medical devices (cardiovascular, endovascular, or other critical care / surgical products), healthcare, or a related environment preferred.Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process ValidationExperience 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 ControlProven expertise in the usage of MS Office Suite including MS ProjectBasic understanding of statistical techniquesStrong problem-solving, organizational, analytical, and critical thinking skillsJob Responsibilities :
Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programsSupports or leads test method development / validation activities for Design Verification testing and manufacturing inspections for NPD programsInvestigate complex manufacturing product quality issues reported from the field, analyze results, determine root cause / probable cause, and initiate and review reports.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)Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust productsDevelop 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 reportsDevelop, update, and maintain technical content of risk management filesDevelop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processesAssign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician workOther incidental duties assigned by LeadershipAbility to travel up to 10% domestically and internationally
