Job Title: Engineer III
Location: Irvine, CA - Hybrid Required (M/F Remote - T/W/TH Onsite)
Contract: 1 year - based on performance and business needs
Client is looking for a Development Engineer in the Irvine Engineering Testing & Analysis group (ETAG) within Device & Combination Product Development (DCPD). This is a key role with a direct impact on client’s exciting and rapidly growing portfolio of combination products, with a major focus on Eye Care and Neurotoxins products. This role will lead project activities and work on his/her own projects while contributing engineering insights into multiple other projects.
Responsibilities:

• Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals.
• Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
• Define, develop, and validate/transfer test methods.
• Create verification plans, protocols, records, and reports. Support investigations and issue resolutions.
• A degree in an engineering field (mechanical, materials, packaging, bioengineering): BS or equivalent education with 5-10 years of experience; MS or equivalent education with 3+ years of experience
• Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
• Significant background in engineering testing and analysis including:
• Direct experience of test equipment validation (IQ, OQ, PQ) is required.
• Must be able to demonstrate relevant experience in statistical analysis.
• Documentation experience including standard operating procedures (SOPs), technical reports, and design verification plans/protocols/reports.
• Proficiency in MS Office, MS Project, Solidworks, Minitab or JMP.
• Lean Six Sigma, 5S experience desired.
• Good communication skills, both written and oral. Ability to prepare technical reports and presentations.

What are the top 3-5 skills, experience or education required for this position:

• Experience creating engineering drawings, proficiency with GD&T dimensioning, CAD design (Solidworks) and tolerance stack analysis
• Experience with ISO 13485 and 14971 quality system and risk management principles
• Experience with design control, DHF documentation, and good manufacturing/documentation practices
• Experience with fixture design, fixture development, test method validation
• Experience with statistical software (minitab or JMP), Six Sigma statistics and Design of Experiments
  
   

 
 
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: $ 65.00/hr.