Senior Advanced Manufacturing Engineer

Instylla•Burlington, MA

2d•$100,000 - $145,000

About The Position

The Senior Advanced Manufacturing Engineer is a key technical contributor to Instylla’s New Product Development programs for embolic product lines and associated delivery devices. The role partners with R&D from early concept through commercial launch to develop robust, scalable manufacturing processes, provide Design for Manufacturability (DFM) input, and develop and qualify processes at external suppliers and within Instylla’s internal manufacturing operations. The position owns the manufacturing path from process development through creation of the Master Validation Plan (MVP), equipment qualification, and process validation, culminating in delivery of a stable, validated process to Operations through a formal design transfer review. The engineer works cross-functionally with R&D, Production, Quality, Regulatory Affairs, and Supply Chain to ensure activities are planned, controlled, and documented within Instylla’s Quality Management System. Following design transfer, commercial manufacturing process ownership transitions to Manufacturing Engineering – Sustaining.

Requirements

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, or a related discipline.
At least 7 years of experience in manufacturing engineering, advanced manufacturing engineering, or process development for medical devices or a similarly regulated industry, with significant New Product Development experience.
Demonstrated track record of taking new products from development through design transfer into commercial manufacturing.
Proven experience providing DFM input and collaborating with R&D design teams.
Experience developing and qualifying manufacturing processes at external suppliers or 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 FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485, and ISO 14971.
Strong command of statistical tools and methods, including DOE, SPC, process capability (Cpk/Ppk), and Gage R&R, using statistical software such as Minitab.
Proficiency in process risk management (pFMEA) and translating risk controls into process controls.
Experience designing tooling and fixtures; proficiency with 3D CAD software such as 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, and ensure products meet specifications.
Strong project management skills, including planning and managing multiple concurrent projects, meeting deadlines, and prioritizing changing demands.
Excellent written and verbal communication skills and ability to work effectively with peers, R&D, suppliers, auditors, and management.
Self-motivated and well-organized, with the ability to work independently and in cross-functional teams.

Nice To Haves

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.

Responsibilities

Serve as the manufacturing engineering lead on New Product Development 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 reviews to support manufacturable, scalable, cost-effective designs that consistently meet specifications.
Translate design inputs and product requirements into process requirements, process specifications, and critical-to-quality characteristics.
Lead process risk management, including authoring process FMEAs and contributing to design FMEAs and risk management files.
Support engineering, design verification, and clinical builds; capture lessons learned and feed them into product and process design.
Develop manufacturing processes, methods, tooling, fixtures, and equipment from feasibility through commercial-scale production.
Develop processes for early engineering builds and mature them into production-ready processes.
Characterize processes using statistical methods, including DOE, capability studies, and Gage R&R, to establish operating windows and identify critical process parameters.
Specify, source, and qualify manufacturing equipment, test methods, and inspection methods.
Estimate and track manufacturing cost, cycle time, yield, and capacity for new products, and drive improvements before launch.
Partner with external suppliers and contract manufacturers to develop, characterize, and qualify component, material, and subassembly manufacturing processes.
Lead technical supplier engagement, including DFM reviews, first article inspections, process audits, and supplier qualification, 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 in coordination with Production.
Assimilate required supplier technical documentation into the Instylla Quality Management System.
Develop and own the Master Validation Plan for new products, defining 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 in accordance with the Master Validation Plan.
Develop process specifications, work instructions, 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 and deliver a stable, validated process to Operations through design transfer review, including documentation handoff, production personnel training, and transition to sustaining engineering.
Perform responsibilities in accordance with Good Manufacturing Practices and Good Documentation Practices.
Provide technical mentorship and guidance to engineers and technicians on process development, validation, and statistical methods.
Communicate project status, risks, and technical findings to project teams and management, and drive timely resolution of manufacturing issues.