Production Operator, 1st Shift

Kimball Electronics • Indianapolis, IN

2d

About The Position

The Production Operator assembles, tests, and packages finished medical-device products according to production and quality-system procedures. The role uses manufacturing machines and equipment, hand tools, custom fixtures, sub-assemblies, parts, and fasteners, and requires accurate documentation of manufacturing activities in accordance with production procedures and good manufacturing practices. The position supports customer quality, cost, and delivery goals and reports to a Production Supervisor in the Operations department of a medical-device contract manufacturer focused on capital equipment, drug-delivery devices, and disposables.

The operator may work on simple, high-volume devices or complex, low-volume devices; operate automated assembly equipment; verify work using checklists; package and label finished products according to the bill of materials; and record production information in the ERP system and work-order paperwork. The role requires following procedures, maintaining a clean and safe work area, regular attendance, and overtime as required. Over time, the operator is expected to become proficient in assigned jobs, assist with work-order setup and inventory forms, train other associates on proficient jobs, provide improvement ideas, and complete Yellow Belt Training. The schedule is Monday through Friday, 7 a.m. to 3 p.m.

Requirements

• Attention to detail and good documentation skills.
• Ability to work on pharmaceutical products with the end patient in mind.
• Ability to assemble simple devices with short cycle times and high daily volumes and complex devices with long cycle times and low daily volumes.
• Ability to operate automated assembly equipment.
• Ability to operate equipment, fixtures, and test stations according to procedures and training, and record results as specified.
• Ability to read procedures and interpret assembly drawings.
• Ability to stand, stoop, bend, reach, and lift as required.
• Ability to analyze situations accurately and follow applicable procedures.
• Ability to work independently and as part of a team, and work with all levels of the organization.
• Ability to react productively to change and handle other assigned tasks.
• Ability to understand business, legal, and regulatory requirements.
• Ability to work overtime as required.
• Maintain regular attendance according to company guidelines.
• Maintain general knowledge of ISO-13485 certification and FDA CFR/GMP medical-device regulatory requirements.

Nice To Haves

• Medical manufacturing experience is preferred.

Responsibilities

• Assemble, test, and package finished products according to production and quality-system procedures.
• Operate manufacturing machines, automated assembly equipment, fixtures, and test stations according to procedures and training.
• Document manufacturing activities and record results accurately, including Device History Records, ERP production reporting, and work-order paperwork.
• Verify work using checklists and inspect the previous operator’s work when working on a production line.
• Package and label finished products in designated cartons according to the bill of materials.
• Complete work orders within assigned cycle times and schedules.
• Complete inventory forms and assist with work-order setup as required.
• Train other production associates on jobs for which proficiency has been achieved.
• Provide improvement ideas for review and complete Yellow Belt Training.
• Maintain a clean and safe work environment and follow the 5S process.
• Maintain regular attendance and work overtime as required.
• Follow applicable procedures and learn and comply with quality-system and good-documentation practices.

Benefits

• Three weeks of paid time off starting in the first year.
• 10 paid holidays.
• Potential monthly incentive bonus based on company performance.
• Major health, dental, vision, and complementary insurance coverage starting on day one.
• 50% match on the first 6% of 401(k) contributions, with an opportunity for an annual employer contribution.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed