Micro-Assembly Manufacturing Technician (ISO 13485)

STERIS - Operations

Mentor (OH)

On-site

USD 30,000 - 39,000

Full time

4 days ago
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Benefits offered by this job

Market-competitive compensation
Extensive paid time off
401(k) with company match
Maternity and parental leave
Tuition reimbursement

Job summary

STERIS is seeking a Micro-Assembly Manufacturing Technician to operate in an FDA-regulated, ISO 13485 environment. You will assemble medical device components with precision, monitor quality, and perform changeovers as orders shift, ensuring line continuity and compliance.

You will set up baggers/printers for new orders, maintain DHRs, and contribute to continuous improvement through Pareto analysis and Safety/Ideas programs. A high school diploma and relevant experience are required.

Qualifications

  • High school diploma or GED required.
  • 1+ year of small-parts assembly experience preferred.
  • 1 year of crimping and gluing small components.
  • 1 year performing material replenishment tasks.
  • 1 year conducting in-process inspections.
  • 1 year executing changeovers for parts and equipment.
  • 1 year setting up auto baggers and printers for new orders.

Responsibilities

  • Assemble medical device components using hand tools and bench-top equipment to meet production goals.
  • Continuously assess quality of small parts during the build.
  • Operate required equipment and manage changeovers for parts and equipment.
  • Set up auto baggers and printers for new orders; replenish materials to keep the line moving.
  • Complete Device History Records (DHRs) and participate in Process Monitoring.
  • Create Pareto charts to visualize issues and prioritize improvements.
  • Submit Safety Observations and share ideas through company programs.
  • Promptly inform Team Lead of any concerns with production, parts, equipment, or processes.

Skills

Small-parts assembly
Crimping & gluing
Process monitoring
Changeovers
Quality awareness

Education

High school diploma or GED

Tools

Hand tools
Bench-top pneumatic presses

Job description

Micro-Assembly Manufacturing Technician (ISO 13485)At STERIS, our purpose is to support a healthier, safer world. Be part of a team that produces medical devices in a tightly controlled, FDA-regulated setting—where precision and quality define every build.Is This You?Do you thrive working with tiny components and tight tolerances?Can you hit production targets while keeping impeccable records?Do you spot issues early and communicate clearly with your Team Lead?Role SnapshotWork within an FDA-regulated, controlled environment following Shop Practices, proper gowning, PPE, and standard work.Assemble medical device components using hand tools and bench-top pneumatic presses, meeting or exceeding production goals.Continuously assess quality of small parts during the build.Operate required equipment and manage changeovers for parts and equipment as orders shift.Set up auto baggers and printers for new orders; replenish materials to keep the line moving.Complete DHRs (Device History Records), conduct Process Monitoring, and maintain the Hour-by-Hour Board.Create Pareto charts to visualize issues and prioritize improvements.Submit Safety Observations via the Safety Program and share new Ideas through the Ideas Program.Promptly inform the Team Lead of any concerns with production, parts, equipment, or processes.Perform additional duties as assigned.Shift2nd Shift with a $1.25/shift differential.Required QualificationsHigh school diploma or GED.1+ year of small-parts assembly experience.1 year of crimping and gluing small components.1 year performing material replenishment tasks.1 year conducting in-process inspections.1 year executing changeovers for parts and equipment.1 year setting up auto baggers and printers for new orders.Core ProficienciesHigh School / GEDAssemblyBenefits & RewardsWe invest in your well-being, growth, and stability:Market competitive compensationExtensive Paid Time Off plus 9 company holidaysShort- and long-term disability coverage401(k) with company matchMaternity and parental leaveOptional add-on benefits and discounts, including Pet InsuranceTuition reimbursement and continuing education programsExcellent advancement opportunities and a stable, long-term career path
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