Principal 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 ten (10) 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 twelve (12) years of relevant manufacturing process development experience in the medical device industry. 
3. 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 experience with improving existing process capabilities and optimization. 
5. Expertise in process design, optimization, and validation (IQ, OQ, PQ). 
6. Proficiency with statistical tools (e.g., Minitab). 
7. Hands-on experience with manufacturing processes involving hydrophilic coating, polymer fusing, and nitinol stents. 
8. Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt a plus). 
9. Ability to solve complex manufacturing problems. 
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

Principal Engineer, NPI & Transfers

Posting Country

US - United States

Salary Range

$115,000 - $160,000 (Compensation could be higher/lower based on experience, education and skill sets)