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).

Intake Notes:
-100% onsite M-F 8a-5pm
-Minimum 5 yrs experience, no maximum
-High level Sr/Prin Engr that can run tasks with little assistance
-Knowledge of quality systems with ability to generate documents as needed
-Strong risk mgmnt and process development experience
-Production quality support
-Driving design control deliverables, conducting investigations, CAPA, and providing commercial support

Education: Engr background, no specifics but class 3 medical device exp is preferred

Top Skills: Risk mgmnt, design control, investigation, problem solver, works independently, highly regulated quality environments, great communications skills, cross functional teams, able to work in fast paced environments 
 
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.