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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.
