Sr Engineer - Product Development and Manufacturing
Location:
Irvine, CA
Schedule:
8:00 AM – 5:00 PM
Duration:
18-Month Contract
Pay Rate:$53-59/hr
About the Role
Innovation starts from the heart. This organization invests heavily in research and development
to advance breakthrough medical innovations in structural heart disease and critical care.
As part of the Quality Engineering team, you will partner closely with R&D and Manufacturing
teams to support product development, cleanroom build activities, and commercialization efforts—helping bring life-changing medical technologies to patients worldwide.
How You Will Make an Impact
- Perform Quality Engineering activities supporting new product development (NPD) and cleanroom build initiatives
- Ensure NPD processes comply with quality systems and regulatory requirements
- Update and maintain risk management files and design control documentation
- Develop, execute, and validate test methods and qualification plans
- Support design verification, process validation, and commercialization, including multi-site transfers
- Collaborate cross-functionally with R&D, Manufacturing, Regulatory, Clinical, and Marketing teams
- Perform additional duties as assigned by leadership
Required Qualifications
- Bachelor’s degree in Engineering or a Scientific field with 4+ years of experience
- OR
- Master’s degree(or equivalent) in Engineering or a Scientific field with 3+ years of experience
Preferred Qualifications
- Strong understanding of medical device manufacturing and operations(medical device experience strongly preferred)
- Experience in product development, quality assurance, or related disciplines
- Knowledge of Engineering and Quality principles
- Working knowledge of ISO 13485
- Experience developing and maintaining risk management documentation
- Basic understanding of statistical methods; Minitab experience a plus
- Background in test method development, validation, and/or fixture development
- Excellent problem-solving, analytical, and organizational skills
- Strong documentation and communication skills with high attention to detail
- Ability to collaborate effectively across all organizational levels
- Comfortable managing multiple priorities in a fast-paced environment
...