Quality Medical Device Engineer II

This team is a part of the Irvine implant manufacturing plant. They help support components and tissues for all commercial valve sustainment. The reason for the opening is to help support a new project the plant is kicking off!

Day to day:
-Collaborate with cross functional teams to help troubleshoot and resolves issues that arise -See to component and heart valve projects day to day
Skills needed:
-Bachelor's or above in a related engineering field with 2 to 3 years of related experience -Proven track record of being a driven and collaborative engineering team member -Medical device background HIGHLY preferred -MUST be proficient with handling approx. 1-3 NCR's at a time -Familiar with process/equipment validation (IQ/OQ/PQ)
Location:
-Full time onsite at Irvine headquarter
Schedule:
-8 am PST to 5 pm PST
-No OT, work/life balance is important in this team!
Duration:
-12 months with possibility of extension
This is an exciting opportunity within our Irvine Implant Manufacturing Plant supporting Quality Engineering for Components used to build Surgical, THV and TMTT heart valves. The Quality Engineer will be a key member of a cross-functional core team accountable for all aspects of the Components and Valve Assembly operations value stream (safety, quality, delivery, compliance) by supporting sustaining tasks and day-to-day operations.
Job Responsibilities:
Leads investigation of manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Identify and ensure the optimization of Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
Update, and maintain technical content of risk management files.
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
Perform other duties and responsibilities as assigned.
Skills:
Proven expertise in usage of MS Office Suite.
Medical device industry experience required.
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Working knowledge and understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Knowledge of and adherence to Quality systems
Strict attention to detail
Education/Experience:
Bachelor's Degree or equivalent in in Engineering or related field, minimum 2 years related industry experience required or
Master's Degree or equivalent in in Engineering or related field, 1 year experience related industry experience required