Position Title: Principal Engineer
Assignment Duration: 9 Months
Assignment Location: Irvine, CA 92614
Shift: 1st Shift
 
Key Responsibilities:

• Identify and solve complex problems in a multi-stakeholder, team setting where precedent may not exist, using creativity while maintaining compliance with industry regulations.
• Manage cross-functional projects, timelines, and budgets; implement digital quality tools (eQMS, dashboards).
• Translate technical information to all levels of the organization through large and small presentations.
• Independently lead QMS improvement activities and associated projects.
• Own and perform documentation changes and set policies and standards that are followed by others.
• Lead CAPA execution, root cause investigations, and quality data analysis to identify trends.
• Own and drive validation testing (all types), TMV, and software validation testing.
• Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement.
• Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk.
• Drive development and manage execution of complex experiments and tests (including writing and executing protocols) to validate and improve products and establish robust manufacturing processes; ensure completion of process validations (IQ/OQ/PQ), analyze results, and develop reports.

 
Qualification & Experience:

• Bachelor’s or master’s degree in engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences).
• 6 years of experience in medical device engineering or medical device quality roles.
• Travel required ~15%.
• Statistical based software (Minitab, JMP)
• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
• Certified Quality Engineer (CQE) or equivalent.
• Measurement and Test Equipment knowledge and experience are essential.
• Process Validation experience.
• Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge).
• Proficiency in quality tools (FMEA, CAPA, statistical analysis).

 
 
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.