Staff Engineer, NPI & Transfers

Location

Aliso Viejo, California, USA

Department Name

646-R&D Management

Qualifications

1. Bachelor's degree in mechanical/manufacturing/industrial engineering or related field. 
2. A minimum of six (6) years of relevant manufacturing process development experience in the medical device industry. 
3. Strong written and verbal communication skills. 
4. Proficient computer skills including MS Word, Excel, Outlook, Teams, and CAD. 

1. Advanced degree in Engineering or related field. 
2. A minimum of eight (8) years of relevant manufacturing process development experience in the medical device industry. 
3. Proven ability to design, develop, and validate manufacturing processes of medical devices and working knowledge of cGMP. 
4. Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development, characterization, and optimization preferred. 
5. Knowledge of process design, optimization and validation (IQ, OQ, PQ). 
6. Familiarity with statistical tools (e.g., Minitab). 
7. Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt a plus). 
8. Ability to solve complex manufacturing problems. 
9. Demonstrated ability to improve process capacity and improve yield. 
10. Ability to read and prepare technical documentation. 
11. Knowledge of medical and technical development as well as international regulations for medical devices. 
12. Strong problem solving and conflict management skills. 
13. Proficiency with SolidWorks and fixture design preferred.

External-Facing Title

Staff Engineer, NPI & Transfers

Posting Country

US - United States

Salary Range

$111,000 - $146,000 (Compensation could be higher/lower based on experience, education and skill sets)