Job description

POSITION SUMMARY

This position is responsible for cleanroom assembled disposable fiber-optic product to support a new De Novo medical device product while meeting all customer specifications; controls and manages all documentation pertaining to manufacturing matters; assists with technical issues, and training of new assemblers.

ESSENTIAL FUNCTIONS

1. Work in a cleanroom ISO class 7 environment

2. Follow detailed work instructions, SOPs, Batch Record documentation procedures, operate machines and use appropriate fixtures to correctly assemble/package small parts and finished goods.

3. Comply with the policies, guidelines, gowning protocols and FDA regulatory requirements of the Lumoptik Quality System Manual. Always maintain GDP/GMP compliance, maintain training records, maintain Class 7 clean room condition, safely store hazardous materials, and properly store in process materials and subassemblies.

4. Report problems with quality, processes, equipment, or materials to the Production Supervisor or Production Manager.

5. Complete routine tasks with minimal supervision.

6. Maintain a clean and organized work area to facilitate cGMP

7. Conduct daily, weekly and monthly cleaning protocols of ISO class 7 clean room and anti-room.

8. Assist in product/process development and validation in the clean room environment.

9. Maintain inventory for Clean Room Supplies.

10. Assist in monitoring safety practices and quality compliance.

11. Cross train and or support other work venues as needed.

12. Participate in any Lean or process improvement initiatives.

13. Ability to work independently, as well as with multiple departments.

POSITION QUALIFICATIONS

Education and Experience

1. Prior experience handling medical devices is desired. However, training is available.

2. Leadership and people skills.

3. Ability to communicate clearly and effectively.

4. Proven attention to detail and multi-tasking abilities.

5. Understand the importance of meeting quality and productivity standards.

6. Ability to thrive in a fast-paced environment.

7. Bending, lifting, climbing.

Language Skills

Has strong written and verbal control of the English language, ability to communicate effectively with others and be clearly understood

Mathematical Skills

The ability to add, subtract, multiply, and divide all units of measure including whole numbers, common fractions, trigonometry, geometry and decimals; the ability to compute rate, ratio, draft angles and percentages and interpret graphs and statistics

Reasoning Ability

Has ability to solve practical problems and deal with a variety of concrete situations where only limited standardization exists. Ability to interpret a variety of inputs furnished in written, oral, diagram, or schedule form. Exhibits strong judgment and works with minimal supervision

Computer Operations

Intermediate to advanced personal computer skills; experienced at Microsoft Office applications. Strong knowledge and proficient skills in Solidworks, or similar 3D CAD software as well as working knowledge of the physics of light transmission, reflection, and refraction and units of measure.

Planning and Organization

Ability to effectively prioritize, deal effectively with complexity, organize, multi-task and be detailed oriented. Good organization and communication skills. Able to meet deadlines, follow through on commitments and take corrective action where appropriate

Certificates, Licenses, and Registrations

None

Working Conditions

Well- lighted, heated and air-conditioned indoor office, production and warehouse area with adequate ventilation. Job requires lifting up to 25 pounds less than 1/3 of the time

Physical Activity Level

Light to medium physical activity performing non-strenuous daily activities. Has ability to move and operate freely in office and production areas

Manual Dexterity and Visual Acuity

Manual dexterity and visual acuity sufficient to work with miniature optical and plastic components, as well as microliter volumes of adhesives.

Vision Requirements

Color vision with the ability to identify and distinguish colors

Work Schedule/Hours

Scheduled hours are 8:00am to 5:30pm with a half hour lunch

Travel

Occasional travel to customers, vendors and educational events

Contacts

Communicates internally with individuals in all departments and externally with existing vendors and customers

Reports to

BrightPoint(TM) Production Manager

Job Types: Full-time, Contract

Pay: $25.00 - $30.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Relocation assistance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Spring Grove, IL 60081: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:

• cleanroom assembly: 1 year (Required)
• medical device assembly: 3 years (Required)

Shift availability:

• Day Shift (Required)

Work Location: One location

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