Senior Advanced Manufacturing Engineer

We are NOT accepting resumes from recruitment agencies or search firms. 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: The Senior Advanced Manufacturing Engineer is a key technical contributor to Instylla's New Product Development (NPD) programs for its embolic product lines and associated delivery devices. Working collaboratively with R&D from early concept through commercial launch, the Senior Advanced Manufacturing Engineer will lead the development of robust, scalable manufacturing processes, provide Design for Manufacturability (DFM) input to product designs, and develop and qualify processes at both external suppliers and within Instylla's internal manufacturing operations. This role owns the manufacturing path from process development through creation of the Master Validation Plan (MVP), equipment qualification, and process validation, culminating in the delivery of a stable, validated process to Operations through a formal design transfer review. The successful candidate will work cross-functionally with R&D, Production, Quality, Regulatory Affairs, and Supply Chain to ensure all activities are properly planned, controlled, and documented within Instylla's Quality Management System. Essential Duties & Accountabilities: New Product Development & R&D Collaboration Serve as the manufacturing engineering lead on NPD core teams, partnering with R&D from concept and feasibility through design transfer. Provide Design for Manufacturability and Assembly (DFM/DFA) input during design development and design reviews to ensure designs are manufacturable, scalable, cost-effective, and capable of consistently meeting specifications. Translate design inputs and product requirements into process requirements, process specifications, and critical-to-quality (CTQ) characteristics. Lead process risk management activities, including authoring process FMEAs (pFMEAs) and contributing to design FMEAs and risk management files. Support engineering, design verification, and clinical builds, capturing lessons learned and feeding them back into both the product design and the process design. Process Development & Scale-Up Develop manufacturing processes, methods, tooling, fixtures, and equipment for new products, from feasibility through commercial-scale production. Develop processes to support early engineering builds, then scale and mature them into production-ready processes. Characterize processes using statistical methods (DOE, capability studies, Gage R&R) to establish operating windows and identify critical process parameters. Specify, source, and qualify new manufacturing equipment, test methods, and inspection methods. Estimate and track manufacturing cost, cycle time, yield, and capacity for new products, and drive improvements prior to launch. External Supplier & Internal Manufacturing Development Partner with external suppliers and contract manufacturers to develop, characterize, and qualify component, material, and sub-assembly manufacturing processes. Lead technical engagement with suppliers, including DFM reviews, first article inspections (FAIs), process audits, and supplier qualification activities, in collaboration with Supply Chain and Quality. Contribute to make-versus-buy and supplier selection decisions for new products. Develop and implement internal manufacturing processes, line layouts, and work cells for new products in coordination with Production. Assimilate required supplier technical do…

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