Production Operator, 1st Shift

Position Overview

The mission of the Production Operator is to assemble and pack parts per production procedures and document production processes while meeting goals of quality, cost, and delivery. This role reports to a Production Supervisor within the Operations department of a growing Medical Device contract manufacturer focused on capital equipment, drug delivery devices, and disposables. Additionally, the position is responsible for assembly, testing, and packaging of finished products using manufacturing machines, hand tools, and custom fixtures while complying with production procedures and good manufacturing practices.

Shift: 1st Shift, Monday-Friday, 7am-3pm

Key Responsibilities

• Learn and adhere to KEIND Quality system requirements and Good Documentation Practices.
• Build relationships with Operations, Quality, and Material Handling teams.
• Become self-sufficient in multiple assembly and packaging tasks and accurately complete Work Orders.
• Maintain complete and accurate Device History Records per Good Manufacturing Practices.
• Inspect and report production efficiently using the ERP system and Work Order paperwork.
• Follow the 5S process and maintain a clean and safe work environment.
• Complete inventory forms, assist in work order setup, and provide training to production associates.
• Contribute improvement ideas and complete required training (e.g., Yellow Belt Training).

Required Qualifications

• Attention to detail and strong documentation skills.
• Ability to work on pharmaceutical products with the end patient in mind.
• Experience in assembling simple devices with short cycle times and high daily volumes.
• Experience in assembling complex devices with long cycle times and low daily volumes.
• Proficiency in operating automated assembly equipment.
• Operate equipment, fixtures, and test stations per procedures while recording results as defined.
• Verify work through standardized checklists.
• Packaging and labeling finished products according to BOM.
• Ability to read procedures and interpret assembly drawings.
• Capability to stand, stoop, bend, reach, and lift as required.
• Analytical skills with the ability to follow applicable procedures.
• Ability to work independently and collaboratively across all organization levels.
• Flexibility to react productively to change and manage additional tasks.
• Understanding of business, legal, and regulatory requirements.
• Willingness to work overtime as required.
• Commitment to maintaining a clean and safe working environment.
• Consistent attendance as outlined by company guidelines.
• General knowledge of the certification and regulatory requirements in ISO-13485 and FDA CFR/GMP Medical Device Regulation.

Preferred Qualifications

• Medical manufacturing experience is preferred.

Benefits & Perks

• 3 weeks of PTO starting your 1st year, plus 10 paid holidays.
• Potential monthly incentive bonus based on company performance.
• Major health, dental, vision, and complementary insurances starting day 1.
• 50% match on your first 6% of 401k contribution with additional annual employer contribution.