Principal Engineer, NPI & Transfers

Location MV

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.

EEO
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance
If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

External-Facing Title

Principal Engineer, NPI & Transfers

Posting Country

US - United States

Salary Range

$129,075 - $169,411 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.