R&D Engineer II

Job Type

Full-time

Description

About us:

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. 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 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.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

Role:

The R&D II Engineer will be responsible for designing and developing catheters from concept to production, ensuring they exceed customer expectations.

Job Responsibilities:

• Execute design, development, and validation activities throughout the product life cycle in accordance with project scope.
• Utilize the Design Control process to create cost-effective and efficiently manufacturable products.
• Contribute to deliverables in compliance with MDR, ISO, and EN standards.
• Translate customer specifications and requirements into clear, concise performance and functional requirements.
• Conduct engineering evaluations, characterizations, design of experiments (DOE), bench testing, and other verification activities to improve and confirm design and process capabilities.
• Train and guide development technicians/operators in hands-on prototyping, testing, and process development.
• Execute document change requests and effectively train development/production operators and technicians on updated documentation.
• Design, procure, install, qualify, document, and train on new tooling/fixturing.
• Evaluate and implement new technologies and ideas for product improvement.
• Use statistical tools to analyze data and make development decisions to enhance process capability.
• Develop and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
  
  

Requirements

• Preferred 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.