Principle Engineer - Extrusion Subject Matter Expert (SME) Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team. There is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' lives and the lives of the patients that depend on our products. Biomerics is seeking an experienced Principle Engineer - Extrusion Subject Matter Expert (SME) to serve as the technical engineering lead for new medical extrusion projects. The SME will provide technical steering from initial customer engagement and estimating through development, validation, technology transfer, and commercial launch. This role is the principal technical resource for selecting materials, processes, tooling, and equipment; defining scientifically sound development and validation strategies; and guiding customers and cross-functional teams toward manufacturable extrusion solutions. The SME will partner closely with Commercial, Estimating, Program Management, Quality, Manufacturing, Supply Chain, and Operations to ensure project scope, non-recurring engineering (NRE) estimates, piece-part costs, schedules, and technical deliverables are accurate and aligned. The successful candidate will combine deep medical extrusion expertise with strong customer-facing communication, project technical leadership, and the ability to identify and implement new extrusion technologies across the organization.
Responsibilities:
Serve as the technical engineering lead and subject matter expert for new extrusion programs from opportunity assessment through validation and production handoff.
Provide technical direction and decision-making for single-lumen, multi-lumen, coextruded, braided, and other complex medical tubing applications, as applicable.
Translate customer requirements into practical extrusion concepts, development plans, process requirements, and acceptance criteria.
Identify the appropriate polymer materials, extrusion processes, tooling, downstream equipment, inspection methods, and manufacturing technologies for each application.
Lead design-for-manufacturability reviews and recommend product or process changes that improve capability, quality, scalability, and cost.
Establish the technical approach for process characterization, development testing, risk reduction, and validation readiness.
Customer Technical Steering:
Partner with Commercial Directors and customer teams to build confidence in Biomerics' extrusion capabilities and define a technically viable path to commercialization. Lead technical discussions with customers, including requirements reviews, material and process selection, design tradeoffs, development results, technical risks, and validation strategy. Present development findings, explain technical recommendations, and drive timely alignment on decisions, actions, and project direction. Support resolution of complex technical challenges while maintaining clear communication of assumptions, constraints, risks, and impacts to cost or schedule.
Estimating and Proposal Support:
Partner with the Estimating team and Commercial organization to develop accurate technical scopes and quotations for new extrusion opportunities. Define and estimate project-related NRE requirements, including engineering labor, development runs, materials, tooling, fixtures, testing, inspection, validation, and outside services. Provide technical inputs for piece-part cost models, including material selection and usage, cycle rate, yield assumptions, labor content, setup requirements, equipment utilization, inspection, and packaging considerations. Review quotes for technical completeness, feasibility, risk, and alignment with the proposed development and validation plan before customer submission. Support cost reviews for strategic and capital-intensive opportunities and identify options to improve technical value and commercial competitiveness.
Technology and Capital Project Leadership:
Work with cross-functional teams to identify, evaluate, develop, and implement new extrusion technologies that expand capability or improve quality, capacity, cost, and speed to market. Lead extrusion capital projects from technical concept and business case through equipment specification, supplier selection, factory acceptance, installation, qualification, and operational handoff. Develop user requirements and technical specifications for extrusion lines, tooling systems, material handling, downstream processing, and inspection equipment. Coordinate trials and capability assessments with suppliers, customers, and internal stakeholders; document conclusions and implementation recommendations. Maintain awareness of emerging polymers, extrusion methods, tooling approaches, controls, automation, and inspection technologies relevant to minimally invasive medical devices.
Project Planning, Development, and Validation:
Participate as a core member of cross-functional project teams responsible for project scope, timelines, resource planning, risk management, development execution, validation, and launch. Provide accurate technical task durations, dependencies, resource requirements, and risk-based contingencies for project schedules. Lead or technically approve process characterization studies using engineering fundamentals, Design of Experiments (DOE), statistical analysis, and documented development run data. Define robust process windows and ensure critical process parameters, outputs, controls, and inspection methods are appropriately established before validation. Provide technical leadership for IQ, OQ, PQ, test method validation (TMV), process capability studies, and other required verification and validation activities. Support technology transfer and production handoff by confirming documentation, training, equipment, tooling, inspection methods, process controls, and manufacturing readiness.
Cross-Functional Collaboration and Technical Excellence:
Collaborate with Program Management, Quality, Regulatory, Manufacturing, Operations, Supply Chain, Finance, Commercial, and site leadership to deliver successful extrusion programs.
Provide technical mentorship and guidance to engineers and technicians without requiring direct people-management responsibility.
Contribute to standardized extrusion development methods, design guidelines, quote assumptions, process characterization formats, validation templates, and lessons learned.
Support investigation and resolution of high-impact technical issues related to new product introduction and early production stabilization.
Promote a culture of technical rigor, curiosity, accountability, collaboration, and continuous improvement.
Requirements:
Bachelor's degree in Mechanical Engineering, Polymer Engineering, Plastics Engineering, Materials Science, Chemical Engineering, or a related technical discipline.8+ years of engineering experience in medical extrusion, catheter manufacturing, polymer processing, or regulated medical device development. Demonstrated expertise developing, characterizing, validating, and transferring medical extrusion processes into production. Strong knowledge of medical-grade polymers such as Pebax, Nylon, Polyurethane, Polyethylene, fluoropolymers, and comparable materials. Strong understanding of extrusion tooling, screw and barrel design, material drying and handling, cooling, puller and cutting systems, downstream processing, inspection, and process optimization. Experience developing technical project scopes, NRE estimates, capital requirements, timelines, and manufacturing cost inputs. Working knowledge of FDA Quality System requirements, ISO 13485, design controls, risk management, and medical device process validation. Excellent written, verbal, and presentation skills, with the ability to communicate complex technical concepts to customers, executives, and cross-functional teams. Ability to lead through technical influence, facilitate decisions, manage ambiguity, and balance customer requirements with manufacturability, quality, cost, and schedule.
Preferred Qualifications:
Advanced degree in Engineering, Polymer Science, Materials Science, or a related discipline.
Experience with complex catheter, structural heart, vascular, neurovascular, endoscopy, or other minimally invasive medical device applications.
Strong background in DOE, statistical process control (SPC), process capability, measurement system analysis, TMV, IQ/OQ/PQ, and validation strategy.
Experience leading extrusion capital projects and qualifying new equipment, tooling, automation, or inspection technologies.
Experience supporting customer-facing engineering, technical sales, proposal development, and cost modeling.
Lean Manufacturing, Six Sigma, or formal project management training or certification.
Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term
