This engineer is responsible for process development of new manufacturing equipment and improvements to existing processes. This individual works within a team under the leadership of a project manager and is expected to work and communicate well with other team members and leadership.
Primary Duties Uses engineering concepts, company SOPs, and department SOPs to solve a variety of engineering problems. Writes work instructions, design documentation, test cases, validation documentation, engineering investigation reports, and other documents associated with process development. Responsible for process development of new manufacturing equipment and improvements to existing processes (MSAs, DOEs, capability analysis, SPC). Interfaces with program management, project management, engineers, manufacturing line personnel, quality assurance, and others in the development of manufacturing processes. Reports to project management on all tasks and timelines.
- Works on problems of limited scope and complexity.
- Receives moderate oversight from a senior engineer.
- Works on problems of moderate scope and complexity.
- Receives some oversight from a senior engineer.
Training and Education
Requires a bachelor’s degree in Engineering or equivalent.
Engineer II – two years minimum process/manufacturing engineering experience required.
Engineer III - five years minimum process/manufacturing engineering experience required.
Knowledge, Skills, and Abilities
- Strong analytical skills.
- Experience with process validation (IQ, OQ, PQ), including writing protocols and reports.
- Experience with risk analysis and FMEA’s.
- Knowledge and practical application of statistical analysis tools (2 sample t-test, ANOVA, proportion testing, etc.).
- Skilled in Microsoft applications (Word, Excel, etc.).
- Knowledge of statistical analysis software (Minitab preferred).
- Knowledge of the Six Sigma problem solving method (Six Sigma Greenbelt preferred).
- Knowledge of FDA design controls strongly preferred.
- Ability to design, run, and analyze full and fractional factorial DOEs with minimal supervision.
- Ability to perform measurement system analysis with minimal supervision.