Engineer II, NPI & Transfers

Terumo Neuro; Aliso Viejo (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Terumo Neuro in Aliso Viejo, CA seeks an Engineer II, NPI & Transfers to support new product introductions, process development, and transfer activities across manufacturing facilities.

You will draft manufacturing docs, validate processes, collaborate with design and quality teams, and lead prototype builds while ensuring manufacturability and compliance.

Bachelor's degree in engineering and at least two years experience required; SolidWorks proficiency and statistical process methods are a plus.

Qualifications

• Bachelor of Science degree in Engineering or a related field.
• A minimum of two (2) years of relevant manufacturing process development experience.
• Demonstrated expertise with inferential statistical process analysis techniques.
• Demonstrated expertise with mechanical design methods using SolidWorks.
• Strong written and verbal communication skills, organizational skills, and ability to work in a fast-paced, self-directed environment.
• Proficient with MS Word, Excel, Teams, and Outlook.

Responsibilities

• Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
• Draft and execute validation of product, equipment, and processes.
• Provide mechanical design concepts for new equipment and fixturing to improve manufacturing process capability, capacity, efficiency, cost, and quality.
• Lead builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Support projects related to process validation and product transfer activities across different manufacturing facilities and product lines.
• Develop manufacturing documents (e.g., MP, Routers, BOM, Drawings, Specifications, etc.)
• Develop and maintain project timelines, milestones, and deliverables to ensure smooth execution of the NPI process
• Collaborate with the quality team to establish testing and inspection protocols toensure the final product meets quality standards
• Collaborate with design engineers to optimize product designs for efficient manufacturing and assembly processes
• Review product designs to identify potential manufacturability and assembly issues, providing recommendations for improvements
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
• Perform additional duties as assigned

Skills

Statistical methods

Manufacturing process development

Communication skills

Data analysis

Education

Bachelor of Science in Engineering

Tools

SolidWorks

Job description

13724BR

Job Description:

Responsible for supporting medical devices for both existing and new product development, production, and processes. This includes creating or verifying specifications, maintaining, and enhancing product processes, and designing fixtures and equipment, testing processes, equipment, test methods, and raw materials to ensure that the concepts and prototypes meet their specifications. Support projects related to new product introductions, process development engineering, quality systems improvement, and other engineering tasks. Evaluate, initiate, and establish improved engineering and process validation.

Job Duties:

1. Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures

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

3. Provide mechanical design concepts for new equipment and fixturing to improve manufacturing process capability, capacity, efficiency, cost, and quality

4. Lead builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning

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

6. Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes

7. Support projects related to process validation and product transfer activities across different manufacturing facilities and product lines

8. Develop manufacturing documents (e.g., MP, Routers, BOM, Drawings, Specifications, etc.)

9. Develop and maintain project timelines, milestones, and deliverables to ensure smooth execution of the NPI process

10. Collaborate with the quality team to establish testing and inspection protocols toensure the final product meets quality standards

11. Collaborate with design engineers to optimize product designs for efficient manufacturing and assembly processes

12. Review product designs to identify potential manufacturability and assembly issues, providing recommendations for improvements

13. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization

14. Perform additional duties as assigned

Qualifications:

1. Bachelor of Science degree in Engineering or a related field

2. A minimum of two (2) years of relevant manufacturing process development experience

3. Demonstrated expertise with inferential statistical process analysis techniques

4. Demonstrated expertise with mechanical design methods using SolidWorks

5. Strong written and verbal communication skills, organizational skills, and ability to work in a fast-paced, self-directed environment

6. Proficient with MS Word, Excel, Teams, and Outlook

Desired Qualifications:

1. A minimum of four (4) years of relevant manufacturing process development experience

2. Experience in Process Validations in medical device manufacturing environment

3. Experience in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization

4. Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings

5. Demonstrated expertise related to mechanical design of manufacturing equipment, fixturing, and tooling

6. Experience with Six Sigma or Lean methodologies is advantageous

7. Excellent problem-solving skills and ability to work in a dynamic environment

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.

Title:

Engineer II, NPI & Transfers

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.