Production Operator, 2nd Shift

Kimball Electronics•Indianapolis, IN

About The Position

The Production Associate assembles and packs parts according to production procedures and documents manufacturing processes while meeting customer goals for quality, cost, and delivery. The role reports to a Production Specialist in the Operations department of a medical-device contract manufacturer focused on capital equipment, drug delivery devices, and disposables. The position involves assembling, testing, and packaging finished products according to production and quality-system procedures. Work uses manufacturing machines and equipment, hand tools, custom fixtures, sub-assemblies, parts, and fasteners. The employee documents manufacturing activities in accordance with production procedures and Good Manufacturing Practices. The role is scheduled for the second shift, 3 p.m. to 11 p.m., Monday through Friday, with overtime when necessary.

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, as well as 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 defined by documentation.
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 a member of a team, and work with all levels of the organization.
Ability to understand business, legal, and regulatory requirements.
General knowledge of certification and regulatory requirements contained in ISO 13485 and FDA CFR/GMP Medical Device Regulation.
Ability to work overtime as required.
Medical manufacturing experience is preferred, not required.

Nice To Haves

Medical manufacturing experience.

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 as required, including complete and accurate Device History Records and production reports in the ERP system and on 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 needed.
Learn quality-system requirements and Good Documentation Practices, and follow applicable procedures and regulatory requirements.
Maintain a clean and safe work environment, follow the 5S process, and maintain regular attendance under company guidelines.
Work overtime as required to support customer satisfaction.
Build working relationships with Operations, Quality, and Material Handling team members; work independently and as part of a team.
Train other production associates on jobs after achieving proficiency and provide improvement ideas for review.
Complete Yellow Belt Training.
React productively to change and perform other assigned tasks.

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 the first day.
50% match on the first 6% of 401(k) contributions, with the opportunity for an annual employer contribution.

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