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Position Summary:
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.
Role and Responsibilities:
Idea Generation & Innovation:
- 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.
Concept Development & Iteration:
- 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.
Design Control:
- 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.
Cross-functional Collaboration & Leadership:
- 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.
Technical Documentation:
- 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.
Qualifications and Education Requirements:
- 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 regulations (21 CFR Part 820), ISO 13485, and ISO 14971 risk management.
- Hands-on experience with catheter-based, embolic, or implantable vascular device design preferred.
- Proficiency in CAD modeling (SolidWorks or equivalent) and simulation.
- Proven experience authoring DHF documentation and participating in regulatory submissions.
- Strong analytical and problem-solving skills with the ability to interpret complex bench and pre-clinical data.
Knowledge/Skills:
Core Competencies:
- Creative Vision - Generates original, clinically meaningful product concepts and champions them through development.
- Technical Rigor - Applies first-principles engineering thinking with a high standard for data quality and documentation.
- Adaptability - Thrives in a fast-paced start-up environment; adjusts priorities as program and business needs evolve.
- Communication - Communicates complex technical concepts clearly to cross-functional and executive audiences.
- Ownership - Takes full accountability for program deliverables from concept to design freeze.
- Collaboration - Builds productive relationships across R&D, Quality, Regulatory, Clinical, and Operations.
Preferred Skills:
- Experience with peripheral vascular, neurovascular, or embolic occlusion technologies (coils, microspheres, liquid embolics, or plugs).
- Experience with computational flow dynamics (CFD) or finite element analysis (FEA) for device design support.
- Working knowledge of FDA 510(k) or PMA submission processes and pre-submission (Q-Sub) interactions.
- Exposure to human factors engineering (IEC 62366) and usability study design.
- Patent portfolio contributions or history of intellectual property disclosure.
Working Conditions:
- This position primarily operates in a laboratory and office environment. Occasional exposure to biological materials and medical device prototypes in a controlled lab setting. Some travel may be required to visit clinical sites, attend industry conferences, or support supplier qualification activities.
