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R&D Engineer II
2 months ago
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 designing, developing, and producing medical devices for diagnostic and interventional procedures. Our focus is on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
We are dedicated to our diverse employee base and understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions.
It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.
Role and ResponsibilitiesThe R&D II Engineer will be responsible for designing and developing catheters from concept to production, ensuring they exceed customer expectations.
The successful candidate will execute design, development, and validation activities throughout the product life cycle in accordance with project scope. They will utilize the Design Control process to create cost-effective and efficiently manufacturable products.
The R&D II Engineer will contribute to deliverables in compliance with MDR, ISO, and EN standards. They will translate customer specifications and requirements into clear, concise performance and functional requirements.
The engineer will conduct engineering evaluations, characterizations, design of experiments (DOE), bench testing, and other verification activities to improve and confirm design and process capabilities.
They will train and guide development technicians/operators in hands-on prototyping, testing, and process development. The R&D II Engineer will execute document change requests and effectively train development/production operators and technicians on updated documentation.
They will design, procure, install, qualify, document, and train on new tooling/fixturing. The engineer will evaluate and implement new technologies and ideas for product improvement.
They will use statistical tools to analyze data and make development decisions to enhance process capability. The R&D II Engineer will develop and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
RequirementsPreferred Bachelor's Degree in Engineering with 2-5 years of medical device experience, or a combination of work history in the medical device or relevant field totaling 5-8 years.
Strong understanding of design controls, process development, and characterization of test methods for selection, verification, and validation of components, sub-systems, and assemblies.
Proficiency in 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications such as GD&T.
Complex problem-solving skills, including the use of statistical techniques such as DOE, ANOVA, t-tests, normality, and process capability metrics in decision-making.
Strong technical writing skills.
Excellent internal and external communication, presentation, follow-through, and organizational skills.
Proven ability to work effectively with coworkers at all levels of the organization.
