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Job Title: R&D Engineer for Electrophysiology Catheters
Location: Brooklyn Park, MN
Company Overview: 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 the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. At Biomerics, we are dedicated to our employees, because we understand that a strong, skilled, happy workforce is the foundation of a successful business!
Job Description: The R&D Engineer for Electrophysiology Catheters is a high-performing individual that will drive the development of the Electrophysiology Catheter Medical Device manufacturing processes from prototype assembly to production manufacturing. The desired individual will possess a broad range of medical device design and development skills and experience. Applies knowledge and expertise acquired through progressive experience to resolve crucial design issues and/or unique conditions for Electrophysiology Catheter. Keeps informed of new methods and developments affecting their projects. Routinely serves as technical lead for Electrophysiology Catheters. Provides direction for technicians and PDE I level resources with support from management. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, entrepreneurial environment. The Electrophysiology Cather Research & Design Engineer knows the customers, markets, business, and competitors. This Engineer must have experience with Electrophysiology Catheter device design and builds for electrophysiology cardiovascular medical devices (Catheter-based Balloons, Stents, Atherectomy, Thrombectomy, and Micro-catheters). Must have solid experience in handle design, deflectable device design, basic electrical, medical device design practice and project lead experience.
The Research and Design Engineer will develop product specifications, designs, materials, and processes for projects of moderate complexity with minimal supervision/guidance for Electrophysiology Catheters. You will routinely interface and collaborate with doctors and electrophysiology specialist. You will collect data and perform various forms of engineering analysis to make informed decisions or recommendations.
Collaborates within and leads across functional departments
Collaborates within and leads across project teams
Meets and/or exceeds goals and objectives
Activities typically include the following:
Medical Device product research and development, sustaining engineering, engineering analysis (force/stress/strain analysis, tolerance analysis, materials analysis, process capability analysis, industry standards analysis, etc.), animal studies, preclinical studies, clinical studies, and documentation (engineering drawings, engineering characterization reports, assembly procedures, flowcharts, test plans, test reports, etc.)
Interfacing with doctors and electrophysiology specialists on a routine basis
Lead the design of new or existing components and/or devices while ensuring that all design requirements are met
Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements
Prepare design concepts and conducts electrophysiology engineering design reviews
Work independently to plan and schedule activities necessary to meet timelines
Design and coordinate execution of engineering experiments and formal verification tests
Study specifications, engineering blueprints, tool orders, and shop data and confer with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost
Design, procure, and fabricate tooling and fixtures
Perform troubleshooting on new products/process problems as related to design, material, or process
Analyzes, summarizes, and draws conclusions from test results
Prepare standard reports/documentation to communicate results to technical community
Responsible for engineering documentation
Invents/creates concepts and designs for new products/processes, and submits invention disclosures
Lead internal engineers in development of electrophysiology catheter prototypes and test method development of electro-mechanical as well as electrophysiology medical devices
Train and/or provide work direction to engineering support personnel, interns, co-ops, consultants, etc.
Work cooperatively with marketing, manufacturing, process development, quality, regulatory, and clinical to ensure project success
Demonstrates standard product development process and business processes/systems knowledge through delivery of high quality deliverables
Must have experience with Electrophysiology Catheter device design and builds for electrophysiology cardiovascular medical devices (Catheter-based Balloons, Stents, Atherectomy, Thrombectomy, and Micro-catheters).
Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or equivalent degree
5+ years of related work experience or equivalent combination of education and work experience
Cryobased catheter experience is a plus!
Mapping and Ablation catheters experience
Braiding and Coiling experience desired
Risk Analysis experience
Vendor Contract experience
SolidWorks design experience
Demonstrates strong oral and written communication skills
Demonstrates strong leadership skills
Good interpersonal and customer service skills
Ability to work in a fast-paced environment
Ability to take ownership of projects, teams and strive for success
Ability to build strong working relationships
Ability to lead projects, teams and strive for success
Electrophysiology Medical Device or electrophysiology experience required
Problem solving experience
Ability to travel to other local sites 1 or 2 times per week
Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, 401k, Onsite Fitness Facility
Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).