R&D Technician

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

About Instylla:

Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups. The company’s flagship product, Embrace™ Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.

Position Summary/Role and Responsibilities:

We are seeking a hands-on Laboratory Technician to take ownership of Instylla's R&D lab. This role combines bench-top product testing, test method and prototype development with responsibility for organizing, maintaining, and controlling the overall lab environment.

• Execute product verification and validation testing per approved protocols (mechanical, dimensional, functional, and simulated-use testing) on all Instylla products.
• Accurately record raw data, deviations, and observations per GDP.
• Summarize and organize test data to facilitate analysis.
• Set up and coordinate calibration of lab equipment as needed.
• Fabricate or modify test fixtures and setups as needed for new test methods.
• Assist R&D with test method development.
• Support root-cause investigations, NCMRs, and CAPAs with hands-on testing and data collection.
• Support prototype generation through use of 3D printing, adhesive assembly etc. and bench evaluation of new device concepts to assist R&D engineers.
• Own overall organization, cleanliness, and safety of the lab space.
• Maintain inventory of lab consumables, test materials, and fixtures; manage purchasing and reordering.
• Own and maintain lab-related SOPs, work instructions, and equipment usage logs.
• Serve as the lab's point of contact.
• Coordinate lab scheduling to avoid equipment/resource conflicts if needed.
• Onboard and train new lab users on equipment operation and lab procedures.

Qualifications and Education Requirements:

• High school diploma or equivalent required; technical certification, associate's degree, or military/vocational training in a technical field a plus.
• 2+ years of experience in a medical device, lab, or manufacturing environment; peripheral vascular/embolic device experience a strong plus.
• Working knowledge of GDP, GMP, and ISO 13485 / 21 CFR 820 quality system requirements.
• Experience with mechanical test equipment (Instron or similar), calibration processes, and basic statistics.
• Highly organized, self-directed, and comfortable owning a space with minimal oversight.
• Strong written communication skis.
• Proficiency with MS Office/Excel; experience with eQMS platforms is a plus.