A leading medical device company in Irvine, California are looking for an Engineer II to join them onsite for an initial 12 month contract with extension possible! This team is a part of the Irvine Implant Manufacturing plant. Here, you would be helping support components and tissues for all commercial valve sustainment. On a daily basis, you would find yourself collaborating with cross-functional teams to help troubleshoot and resolve issues that arise. Your day would begin at 8am and finish at 5pm PST, with no overtime as this team values a healthy work/life balance!
Hourly Pay Range: $44-$47 dollars an hour (dependant on experience)
Some Key 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.
Some Key Requirements:
- 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
- Substantial understanding of processes and equipment used in assigned work
- Knowledge of and adherence to Quality systems
- Strong understanding of applicable FDA regulations and ISO13485 for medical device industry.
- 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
If you feel like a good fit for this position, please apply with a recent resume to be considered!