What are the responsibilities and job description for the senior Engineer position at Intellectt Inc?
Role: Senior Engineer
Location: Irvine, California – 92614
Duration:06 Months on W2
Space Designation: Onsite = dedicated workspace & at least 80% onsite
Summary
Job Description
This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Edwards Global Supply Chain.
This Cross Functional Partner Will
Location: Irvine, California – 92614
Duration:06 Months on W2
Space Designation: Onsite = dedicated workspace & at least 80% onsite
Summary
Job Description
This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Edwards Global Supply Chain.
This Cross Functional Partner Will
- interact with various functional departments to accomplish compliance and implementation of quality goals within Pilot Manufacturing,
- work with new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and
- support product transfer from Pilot Manufacturing to receiving site manufacturing facilities.
- Work with new product development teams (Implants, Delivery Systems and/or Accessories) to help them efficiently navigate the Edwards' Quality System in order to build quality system test samples and human use product according to project schedules
- Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
- Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
- Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop/drive improvements for inspection test methods
- Lead test method validation activities for in-process inspections
- Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products
- Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
- Bachelor's degree in engineering required.
- 5-7 years experience required.
Senior Engineer
Proteor -
Irvine, CA
Project Engineer / Senior Project Engineer / Geotechnical Engineer
LGC Geotechnical, Inc. -
San Clemente, CA
Remote Senior Data Engineer
Get It - Professional Services -
Irvine, CA
