Senior R&D Engineer

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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.

Instylla Inc. is seeking an experienced and innovative Senior R&D Engineer to join our Research and Development team. In this senior individual-contributor role, you will be a primary driver of innovation across Instylla's peripheral embolic technology portfolio, concentrated on upstream design lifecycle from early ideation through design freeze. You will work at the intersection of clinical insight, engineering rigor, and creative problem-solving to advance next-generation embolic solutions that improve patient outcomes.

• Lead structured and unstructured ideation sessions to generate novel concepts for peripheral embolic devices and delivery systems.
• Synthesize inputs from clinical advisors, field teams, competitive intelligence, and published literature to identify unmet clinical needs.
• Distill inputs from field teams and product users to identify opportunities for product enhancement.
• Develop and maintain an innovation pipeline, evaluating concepts for technical feasibility, clinical value, and regulatory pathway viability.
• Champion a culture of creativity and scientific curiosity within the R&D team.

• Translate early-stage concepts into testable prototypes through rapid, iterative design cycles.
• Apply design thinking methodologies and human factors principles to refine device architecture and user interaction.
• Define and execute bench‑top, computational, in vitro, and/or pre‑clinical evaluation strategies to assess concept performance.
• Drive design iteration based on data, establishing clear go/no‑go decision criteria for advancement through development phases.

• Lead the technical execution of product development milestones in compliance with 21 CFR Part 820 and ISO 13485 quality system requirements.
• Author and maintain critical design history file (DHF) documentation including design inputs, design outputs, verification & validation protocols, and design reviews.
• Define device specifications and performance requirements in alignment with intended use and risk management activities (ISO 14971).
• Coordinate with Quality, Regulatory Affairs, and Clinical teams to ensure design outputs are traceable to validated design inputs.

• Serve as the primary technical authority for assigned programs, representing R&D in project team meetings and design reviews.
• Mentor junior and mid‑level engineers, providing technical guidance and coaching on design methodologies.
• Collaborate with Regulatory Affairs on 510(k), PMA, or De Novo submissions, providing technical sections and responding to FDA inquiries.
• Present program status, technical data, and strategic recommendations to senior leadership and clinical advisors.

• Produce high‑quality technical documentation including design briefs, engineering reports, risk analyses, test protocols, and test reports.
• Maintain rigorous records in the electronic quality management system (eQMS) in compliance with company procedures.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a closely related discipline;
  Master’s or Ph.D. strongly preferred.
• Minimum 8-12 years of progressive R&D experience in the medical device industry, with at least 5 years in an interventional or vascular device environment.
• Demonstrated track record of taking medical device products from concept through design freeze and into commercialization.
• Deep familiarity with FDA design control…