Ultimate Staffing ยท 9 hours ago
Senior Engineer
Irvine, CA
Contract
Onsite
Mid, Senior Level
$55/hr - $60.37/hr
3+ years expUltimate Staffing is focused on driving and developing groundbreaking medical innovations for structural heart disease and critical care. As part of their Quality Engineering team, the Senior Engineer will collaborate with R&D and Manufacturing teams to ensure compliance with quality systems and regulatory standards while developing test methods and supporting product development.
EmploymentHuman ResourcesManufacturingStaffing Agency
Hiring Manager
Brianna Zhong
Responsibilities
Perform Quality Engineering activities related to product development and ongoing cleanroom build support
Ensure NPD processes comply to quality system and applicable regulatory standards
Update risk management and design control files. Maintain relevant quality documentation
Develop and execute test methods 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 assigned by Leadership
Qualification
Required
Bachelor's degree in engineering or Scientific field & 4+ years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field & 3+ years' experience
Preferred
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 (i.e. Minitab) a plus
Experience in test method development including validation and/or fixture development
Solid problem-solving, organizational, analytical, and critical thinking skills
Good documentation and communication (e.g., written and verbal) skills with keen attention to detail
Ability to build productive working relationships and interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Company
Ultimate Staffing
Ultimate Staffing specializes in clerical, administrative, customer service, and manufacturing and production positions.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Lisa Marez
Partnership Director
Company data provided by crunchbase