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 documentation into the Instylla QMS. Process Validation & Design Transfer Develop and own the Master Validation Plan (MVP) for new products, defining the validation strategy, scope, deliverables, and acceptance criteria for equipment, processes, and test methods. Author and execute equipment qualifications, process validation protocols and reports (IQ/OQ/PQ), and test method validations (TMV) in accordance with the MVP. Develop process specifications, work instructions (WIs), manufacturing and inspection procedures, and manufacturing aids in accordance with DHF and DMR requirements. Define and implement in-process controls and monitoring to ensure processes are stable and capable at launch. Lead manufacturing readiness activities and deliver a stable, validated process to Operations through the design transfer review, including documentation handoff, production personnel training, and transition to sustaining engineering. Execute responsibilities in accordance with Good Manufacturing Practices and Good Documentation Practices. Technical Leadership Provide technical mentorship and guidance to engineers and technicians on process development, validation, and statistical methods. Communicate project status, risks, and technical findings clearly to project teams and management, and drive timely resolution of manufacturing issues. Qualifications and Education Requirements: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, or a related discipline. 7+ years of experience in manufacturing engineering, advanced manufacturing engineering, or process development for medical devices or a similarly regulated industry, with significant experience supporting New Product Development. Demonstrated track record of taking new products from development through design transfer into commercial manufacturing. Proven experience providing DFM input and working collaboratively with R&D design teams. Experience developing and qualifying manufacturing processes both at external suppliers/contract manufacturers and in internal manufacturing environments. Hands‑on experience authoring and executing equipment qualifications, process validations (IQ/OQ/PQ), and test method validations. Working knowledge of the FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485, and ISO 14971. Knowledge/Skills: Strong command of statistical tools and methods, including DOE, SPC, process capability (Cpk/Ppk), and Gage R&R, using statistical software (e.g., Minitab). Proficiency in process risk management (pFMEA) and translating risk controls into process controls. Experience designing tooling and fixtures; proficiency with 3D CAD software (SolidWorks or similar) and GD&T. Experience with plastic injection molding, including mold design reviews, molding process development, scientific molding principles, and mold qualification at suppliers. Working knowledge of Good Manufacturing Practices and Good Documentation Practices. Ability to interpret specifications, drawings, technical documents, and procedures, with demonstrated ability to ensure products meet specifications. Strong project management skills, with the ability to plan and manage multiple concurrent projects, meet established deadlines, and prioritize changing demands. Excellent written and verbal communication skills, with the ability to work effectively with peers, R&D, suppliers, auditors, and management. Self‑motivated, well‑organized, and able to work both independently and in cross‑functional teams. Preferred Skills: Master's degree in an engineering discipline. Experience with peripheral embolic devices, catheter‑based therapies, or other vascular/interventional products. Familiarity with embolic materials, including liquid embolics, microspheres, coils, or similar technologies. Knowledge of polymeric materials, adhesives, and/or biocompatible coatings relevant to vascular device manufacturing. Experience with Class II or Class III medical device development and manufacturing, including EU MDR. Experience with chemical processing, such as pharmaceutical or combination product manufacturing. Experience developing semi‑automated or automated manufacturing equipment, and with cleanroom manufacturing, packaging, and sterilization validation. Lean Manufacturing or Six Sigma Green/Black Belt certification; ASQ Certified Quality Engineer (CQE) is a plus. Formal project management training or Project Management Professional (PMP) certification. Experience with ERP systems such as QAD, Oracle, SAP, or similar. Proficiency with inspection techniques using measurement instruments such as gauges, calipers, comparators, vision systems, and microscopes. Good hand/eye coordination and vision abilities, including color vision, close vision, and the ability to see fine details under magnification. Working Conditions: Ability to work in cleanroom garments Ability to work in standing and/or seated positions Ability to lift up to 20 pounds Ability to work in office, chemical laboratory, and assembly environments Ability to travel to supplier sites as required (up to 20%) Additional Notes: This role is focused on New Product Development. Following design transfer, ownership of commercial manufacturing processes transitions to Manufacturing Engineering – Sustaining. #J-18808-Ljbffr Instylla, Inc.