R&D Lab Technician: Medical Devices & Prototyping

Instylla; Bedford (MA); On-site; USD 52,000 - 78,000; Full time

Job summary

Instylla, Inc. is seeking a hands-on Laboratory Technician to lead its R&D lab operations in Bedford, MA. You will perform bench-top product testing, develop test methods, and maintain the lab environment with a focus on compliance and quality.

You will execute verification and validation tests, record data per GDP, calibrate equipment, and assist with prototype evaluation and CAPA investigations. Strong organization and communication are essential.

Qualifications

• 2+ years in a medical device, lab, or manufacturing environment.
• GDP, GMP, and ISO 13485 / 21 CFR 820 knowledge required.
• Experience with mechanical test equipment and basic statistics.
• Highly organized, self-directed, and detail-oriented.
• Proficiency with MS Office/Excel; eQMS experience a plus.

Responsibilities

• Execute product verification and validation testing per approved protocols (mechanical, dimensional, functional, simulated-use).
• Accurately record raw data, deviations, and observations per GDP.
• Summarize and organize test data to facilitate analysis.
• Set up and calibrate lab equipment.
• Fabricate or modify test fixtures for new methods.
• Assist R&D with test method development.
• Support root-cause investigations, NCMRs, and CAPAs with testing and data collection.
• Support prototype generation via 3D printing and bench evaluation.
• Maintain lab organization, cleanliness, and safety; manage inventory and SOPs.
• Onboard and train new lab users.

Skills

Mechanical testing

Data recording

Documentation

Lab safety

MS Office

Education

High school diploma or equivalent

Technical certification or associate's degree (plus)

Military/vocational technical training

Tools

Instron or similar testing equipment

Calibration equipment

MS Excel

eQMS platforms

Job description

Instylla, Inc. is seeking a hands-on Laboratory Technician to lead its R&D lab operations in Bedford, MA. You will perform bench-top product testing, develop test methods, and maintain the lab environment with a focus on compliance and quality.

You will execute verification and validation tests, record data per GDP, calibrate equipment, and assist with prototype evaluation and CAPA investigations. Strong organization and communication are essential.