Engineer I, Manufacturing Process

Terumo Neuro; Aliso Viejo (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Terumo Neuro is seeking an Engineer I, Manufacturing Process to support the development and transfer of medical device manufacturing processes. You will work closely with R&D, Quality, and Regulatory to ensure successful product transfers and scalable production.

The role involves drafting validations, improving processes, and coordinating with planning and operators in prototype and pilot environments. Strong CAD/SolidWorks and documentation skills are essential.

Qualifications

• Bachelor of Science in a related field (e.g., ME, BSChe, EE, IE, PE, etc.).
• Strong written and verbal communication skills.
• Computer skills including Word, Excel, and PowerPoint.
• Proficiency in SolidWorks (and/or CAD) and fixture/tooling design.
• Ability to read and prepare technical documentation.
• Working knowledge of standard machine shop equipment and process.

Responsibilities

• Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures.
• Support validation of product, equipment, and processes.
• Interface with other departments to solve production problems.
• Monitor equipment maintenance program.
• Investigation and testing of product processes.
• Support prototype and pilot production, facilities, and planning when appropriate.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (MP, Routers, BOM, etc.).
• Perform additional duties and responsibilities as assigned.

Skills

Communication

MS Office

SolidWorks

CAD

Technical docs

Machining basics

Education

Bachelor of Science in engineering or related field

Tools

Fixture design

CAD

Job description

14202BR

Job Description:

Support manufacturing process development and manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts, sub-assemblies, finished products, and/or prototypes meet requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch. Job duties:

• Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures.

• Support validation of product, equipment, and processes.

• Interface with other departments to solve production problems.

• Monitor equipment maintenance program.

• Investigation and testing of product processes.

• Support prototype and pilot production, facilities, and planning when appropriate.

• Draft and execute validation of product, equipment, and processes.

• Manage builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.

• Analyze data and improve processes to assure robust/repeatable manufacturing processes.

• Manage process validation and product transfer activities across different manufacturing facilities.

• Review and develop manufacturing documents (MP, Routers, BOM, etc.).

• Perform additional duties and responsibilities as assigned.

Qualifications:

1. Bachelor of Science in a related field (e.g., ME, BSChe, EE, IE, PE, etc.).

2. Strong written and verbal communication skills.

3. Computer skills including Word, Excel, and PowerPoint.

4. Proficiency in SolidWorks (and/or CAD) and fixture/tooling design.

5. Ability to read and prepare technical documentation.

6. Working knowledge of standard machine shop equipment and process.

Desired Qualifications

1. Knowledge of Process Validations in medical device manufacturing environment.

2. Good problem solving and conflict management skills.

3. Knowledge of medical and technical development.

Physical

• Extended periods of working in the machine shop.

• Extended periods of computer use.

• Extended periods of standing or sitting.

• Moderate lifting, up to 50 lbs.

• May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).

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.

Posting Country:

US - United States

Title:

Engineer I, Manufacturing Process

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.