Lead, Production

Terumo Neuro; Aliso Viejo (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Terumo Neuro in California is seeking a Lead, Production to coordinate and supervise assembly teams in a cleanroom environment.

You will ensure materials, processes, and documentation meet GMP/ISO 13485 standards while driving continuous improvement, quality, and on-time delivery. The role requires strong leadership, problem-solving, and collaboration with engineers and staff.

Qualifications

• High school diploma or equivalent.
• Minimum five years of manufacturing experience.
• Ability to do small part assembly under microscope/vision systems.
• Clear English communication with peers and supervisors.
• Ability to follow manufacturing procedures and work instructions.
• Basic math and measurement skills.
• Proficiency with MS Word, Excel, Outlook and Teams.
• GMP/ISO 13485 and quality system understanding.
• Experience with SAP or similar ERP.

Responsibilities

• Provide work direction to assemblers and monitor performance.
• Assist supervisor with production issues, staffing, materials, and equipment.
• Maintain production flow and organization on the line.
• Ensure compliance with quality, safety, and company policies.
• Maintain production metrics and data integrity for records.
• Identify roadblocks and collaborate with staff to resolve issues.

Skills

Leadership

Manufacturing experience

Quality systems

Communication skills

MS Office

Education

High school diploma or equivalent

Tools

SAP

MS Word

Excel

Outlook

Teams

Job description

14279BR

Job Description:

Coordinate production activities to ensure materials, documents, and processes are compliant with the established company practices and procedures. Perform the work in a leadership position under moderate supervision from line supervisor. Assist management in all aspects of operations. Job duties:

• Provide work direction to and monitor performance of all assemblers in the department.

• Assist the supervisor in addressing day-to-day production issues, including staffing needs, material availability, and equipment status.

• Assist supervisor with product flow and organization in the production line.

• Follow and enforce all related quality, compliance, and company policies and procedures.

• Maintain good understanding of department performance goals including quality, cost, delivery, and safety.

• Identify and act on roadblocks that may prevent production line from achieving these performance goals.

• Partner with support staff such as technicians, manufacturing/quality engineers, production supervisor, and warehouse clerks to resolve issues.

• Identify continuous improvement opportunities.

• Give feedback and input on assemblers’ performance reviews.

• Responsible for learning and maintaining knowledge and skills to perform majority of the manufacturing processes successfully.

• Maintain data integrity for work orders/build records, material, training records, etc.

• Maintain and update production metrics.

• Address performance issues in the absence of a supervisor.

• Fill in at a production meeting in the absence of a supervisor.

• Use time and resources efficiently.

• Maintain work area clean and organized.

• Perform assembler, trainer, and material handler responsibilities as necessary.

• 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. High school diploma or equivalent.

2. Minimum five (5) years of manufacturing experience.

3. Ability to do small part assembly work using a microscope, vision system, and/or related automated equipment.

4. Ability to clearly and effectively communicate (read, write and speak in English) with peers, engineers, leads, supervisors, and managers.

5. Ability to follow manufacturing procedures and work instructions.

6. Basic math skills.

7. Knowledge of basic measuring techniques including scales, rulers, and US and metric measurement.

8. Proficiency in assembly procedures, with the ability to train others on the assembly procedures and inspect assemblers’ work.

9. Proficient computer skills including MS Word, Excel, Outlook, and Teams.

10. Strong sense of urgency.

11. Solid understanding of Good Manufacturing Practices/ISO 13485 and company Quality System.

12. Solid understanding of enterprise management systems such as SAP.

13. Solid personal organization skills.

14. General knowledge of cleanroom procedures (such as good documentation practices, line clearance, etc.).

15. Excellent interpersonal skills.

16. Ability to work in a culturally diverse work population.

17. Ability to work overtime as required.

Desired Qualifications

1. Experience in medical device assembly.

2. Minimum six (6) years of manufacturing experience.

3. Experience in leading teams.

Physical

1. Extended periods of working in a cleanroom or controlled environment, adhering to strict gowning and hygiene requirements.

2. Extended periods of sitting or standing.

3. Adequate vision (with or without corrective lenses) and hand-eye coordination for precision assembly work, including performing detailed tasks under a microscope for extended periods.

4. Frequent use of arms, hands, fingers, and wrists for precision work (e.g., gripping, grasping, pinching, twisting, pulling, etc.).

5. Occasional bending, twisting, and reaching.

6. Ability to lift, push, or pull up to 15 lbs. frequently and up to 50 lbs. occasionally.

7. May work with machinery and chemicals, requiring strict adherence to safety protocols.

8. Personal Protective Equipment (PPE), such as gloves, safety glasses, and gowns, may be required in controlled environments.

9. Occasional to moderate use of computer.

10. 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:

Lead, Production

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.