- Manufacturing Experience
- Root Cause Analysis
- Risk Analysis
BioFire Diagnostics is looking for a senior-level Process Engineer to join our growing team!
This individual is responsible for process development of new automation equipment and improvement to existing equipment processes. Works with internal engineers and machine vendors to implement processes in fully automated equipment.
This position will require traveling to external vendors to preform process development. During those times, approximately 50% of your time may be spent abroad.
Writes specifications, WIDs, design documentation, test cases, validation documentation, engineering investigation reports, and other documents associated with the process development to solve a variety of complex engineering problems across functional groups and disciplines.
Problems of significant scope and complexity. Generally works on a team with other engineers, both internal and external. Mentors other team members to develop process development best practices.
Interfaces with program management, project management, engineers, manufacturing line personnel, quality assurance, and others in the development of manufacturing processes. Assists in departmental management and leadership. Works and communicates well with other team members and leadership to which he/she is assigned as well as company management in order to meet the goals of the project. Reports to the project and program management on all tasks and timelines.
Follows company policy, SOPs, WIDs, cGMP, ISO 13485, and FDA guidelines and requirements. Helps implement improvements to safety and manufacturing cost reductions.
Experience with the following is preferred:
Strong analytical skills
Process design input and development
Process validation testing
Participate in deriving and managing product test requirements
Participate in and conduct engineering product design reviews
Perform root cause analysis on failures observed during testing
Excellent testing and "hands on" development aptitude
Experience with Risk Analysis and FMEA’s
Statistics: Knowledge and practical application of 2 sample t-test, anova analysis, proportion test, hypothesis testing, Designing, running, and analyzing full and fractional factorial DOE’s, knowledge of Reliability demonstration test plans, creation of and analyzing Gage R and R’s, and determining appropriate sample sizes
FDA Regulated Industry
This position requires a minimum of a Bachelor's degree or higher in Engineering or equivalent with 10+ years of experience with process development, including performance consistent with said experience.