Chemical Engineer II, NPI & Transfers

Terumo Neuro; Aliso Viejo (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

Terumo Neuro in California seeks a Chemical Engineer II to support NPI and transfer activities, drive process validation, and develop fixtures and equipment for new and existing manufacturing lines.

You will draft manufacturing documents, collaborate with quality, and lead prototype/pilot builds, ensuring processes meet specifications while maintaining ethics and compliance.

Qualifications

• Bachelor of Science degree in Engineering or related field.
• 0–2 years of relevant manufacturing process development experience.
• Experience with inferential statistics in process analysis.
• SolidWorks-based mechanical design experience.
• Strong written and verbal communication, organizational skills.

Responsibilities

• Support new and existing manufacturing processes and related tooling.
• Draft and execute validation of product, equipment, and processes.
• Provide mechanical design concepts to improve manufacturing capability.
• Lead builds for new product development in prototype and pilot production.
• Analyze data to improve repeatable manufacturing processes.
• Coordinate with departments to modify and develop processes.
• Support process validation and product transfer across facilities.
• Create manufacturing documents (MP, Routers, BOM, Drawings, Specifications).

Skills

Inferential statistics

Mechanical design

SolidWorks

MS Word

Excel

Teams

Outlook

Communication

Education

Bachelor of Science in Engineering

Tools

SolidWorks

Job description

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:

• 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 to ensure the final product meets quality standards.
• 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.

Qualifications

1. Bachelor of Science degree in Engineering or a related field.
2. Zero (0) to 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 one (1) year 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.

Physical

• Extended periods of computer use.
• Extended periods of sitting or standing.
• Extended periods working in a cleanroom environment.
• 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

Chemical 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.