Sr. Engineer
Irvine, CA
Schedule:
Standard Hours
Duration:
18-Month Contract
Pay:$54-59/hr (W2)
Our client is a leading global medical technology company. As part of their Quality Engineering team, you will work closely with R&D and Manufacturing teams to develop the latest tools and technologies that address significant, unmet clinical needs impacting patients' lives around the world.
Essential Functions and Responsibilities
- Perform Quality Engineering activities related to product development and ongoing cleanroom build support
- Ensure NPD processes comply with quality system and applicable regulatory standards
- Update risk management and design control files; maintain relevant quality documentation
- Develop and execute test method validations and qualification plans
- Support design verification and facilitate process validation and commercialization activities related to multi-site transfer
- Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing
- Other duties as assigned by Leadership
Education and Experience
- Bachelor's degree in Engineering or Scientific field with 4+ years of experience, OR
- Master's degree or equivalent in Engineering or Scientific field with 3+ years of experience
Knowledge and Skills
- Proficient understanding of medical device operations and/or manufacturing processes; medical device experience strongly preferred
- Relevant experience in product development, quality assurance, and/or related fields
- Knowledge and understanding of Engineering and Quality principles, theories, and concepts
- Understanding of ISO 13485
- Experience developing, updating, and maintaining technical content of risk management files
- Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) a plus
- Experience in test method development including validation and/or fixture development
- Solid problem-solving, organizational, analytical, and critical thinking skills
- Strong documentation and communication skills (written and verbal) with keen attention to detail
- Ability to build productive working relationships and interact professionally across all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Strong preference for candidates with previous experience in NPD, Design Assurance (DA), or Quality Engineering
...