Assembly Technician – Medical Device Manufacturing

Assembly Technician – Medical Device Manufacturing

Location: Janesville, WI

Employment Type: Full-Time

Experience: 5 Years Preferred

Industry: Medical Device Manufacturing

ROLE OVERVIEW

We are seeking an experienced and detail-oriented Assembly Technician to join our manufacturing team in Janesville, WI. This position focuses on the assembly, testing, inspection, repair, and rework of medical-grade equipment and components in a regulated manufacturing environment.

The ideal candidate will have strong hands-on mechanical assembly experience, the ability to read blueprints and technical drawings, and experience using hand tools, power tools, precision measuring equipment, and assembly fixtures. Experience in medical device manufacturing, regulated production, ISO 13485, FDA, or GMP environments is highly preferred.

This is an excellent opportunity for a skilled technician who takes pride in quality, precision, safety, and continuous improvement.

KEY RESPONSIBILITIES

Medical Device Assembly & Production

Perform mechanical assembly of medical devices, components, and sub-assemblies using hand tools, power tools, fixtures, and precision measuring equipment.

Follow engineering drawings, blueprints, schematics, SOPs, work instructions, and production documentation.

Build products accurately and consistently while meeting established production, quality, and delivery requirements.

Perform in-process inspections and visual checks to verify that assemblies meet specifications.

Use calipers, micrometers, gauges, and other measuring instruments to verify dimensions and assembly quality.

Maintain accurate production and assembly documentation in accordance with applicable quality requirements.

Testing, Repair & Rework

Perform functional testing and performance verification of completed assemblies using established procedures and test equipment.

Diagnose assembly issues and perform repair, rework, and corrective adjustments to return products to specification.

Identify recurring defects and communicate issues to supervisors, engineering, and quality personnel.

Document repair, rework, inspection, and testing activities accurately.

Assist with root-cause investigations and corrective actions when required.

Quality & Medical Device Compliance

Follow all applicable medical device manufacturing procedures, SOPs, GMP requirements, and quality system controls.

Work in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements when applicable.

Identify and report non-conforming materials, defective assemblies, safety concerns, and process deviations.

Maintain complete and accurate production and quality records.

Maintain a clean, organized, and controlled work area consistent with 5S and medical device manufacturing standards.

Material Handling & Manufacturing Operations

Safely move and stage components, materials, sub-assemblies, and finished products throughout the manufacturing facility.

Receive, verify, and prepare components and materials for production in coordination with warehouse personnel.

Perform material-handling activities, including lifting and moving equipment, while following established safety and ergonomic procedures.

Operate manufacturing and material-handling equipment as trained and authorized.

Continuous Improvement & Teamwork

Identify opportunities to improve assembly processes, product quality, productivity, and workplace efficiency.

Participate in Lean Manufacturing, 5S, Kaizen, and continuous improvement initiatives.

Work closely with engineers, quality personnel, supervisors, and other technicians to resolve assembly and production issues.

Support cross-training and assist with training new assembly team members.

Help identify bottlenecks and implement practical improvements to support production schedules.

QUALIFICATIONS & EXPERIENCE

High school diploma or GED required.

5 years of hands-on assembly experience, preferably in medical device manufacturing or a regulated manufacturing environment.

Strong mechanical assembly and troubleshooting experience.

Experience working with hand tools, power tools, fixtures, and precision measuring instruments.

Ability to read and interpret blueprints, engineering drawings, schematics, and technical assembly instructions.

Experience with product testing, inspection, repair, and rework.

Understanding of manufacturing quality systems and documentation requirements.

Experience with ISO 13485, FDA 21 CFR Part 820, GMP, or other regulated manufacturing standards is highly preferred.

Associate degree or technical certification in Manufacturing, Mechanical Technology, Biomedical Technology, or a related field is a plus.

REQUIRED SKILLS & COMPETENCIES

Medical Device Assembly & Manufacturing

Mechanical Assembly & Sub-Assembly

Hand tools, power tools, fixtures, and assembly equipment

Calipers, micrometers, gauges, and precision measuring instruments

Blueprint, schematic, and technical drawing interpretation

Product inspection, testing, repair, and rework

Strong attention to detail and quality

GMP and regulated manufacturing practices

ISO 13485 / FDA-regulated manufacturing experience preferred

Lean Manufacturing, 5S, and Kaizen

Strong troubleshooting and problem-solving abilities

Clear verbal and written communication

Ability to work effectively in a team environment

Adaptability and willingness to learn new processes

Strong safety-first mindset

Ability to work flexible schedules and shifts as required

TRAVEL REQUIREMENT

This position requires approximately 10–20% travel within the United States for customer-site support, product installations, field service activities, training, or other business needs.

A valid driver's license and willingness to travel are required.

Pay: $18.70 - $25.95 per hour

Expected hours: 45.0 – 60.0 per week

Application Question(s):

• Medical Device Manufacturing
• Assembly Technician
• 5 years of Medical device

Work Location: In person

Salary : $19 - $26