Job Description
Position Title: Sr Engineer
Work Location: Irvine , CA 92614
Assignment Duration: 18 Months
Work Arrangement: Onsite
Position Summary: As part of our Quality Engineering team, you will work closely with our R&D and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.
Key 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 & Experience:
• 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
• 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
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 55.00/hr.