Senior R&D Engineer

Teleflex•Plymouth, MN

About The Position

This position's responsibility is for managing and developing new products, while interfacing customers, vendors, and internal departments to achieve the desired product specification. The goal is to develop products, define specifications to establish reasonable timelines while developing high quality products that meet the end user’s expectations. Principal ResponsibilitiesThe Senior R&D Engineer is responsible for, managing quick turn medical device OEM projects, responding to Requests for Quotes, and prototyping catheters and balloon sub-assemblies. Candidate must be able to work with minimal supervision in a fast-paced, customer-centric environment; should enjoy communicating with customers, vendors, and internal departments; and be passionate about our goal of consistent on-time delivery of high quality products. This position is ideally suited for experienced Engineers that like to roll up their sleeves and spend time on the production floor, enjoy autonomy, and quick results from their efforts.

Requirements

Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering required
Proven balloon development experience
5 years' or more experience in Medical Device development or manufacturing
Working knowledge of manufacturing processes related to medical device manufacturing
Ability to prioritize and work independently as a self-starter with strong proactive work ethics
Experience with design controls, FDA regulation, GMP practices, and QSR requirements
Proficient in Microsoft Office, Project, Minitab, and Solidworks preferred
Experience with Risk Analyst tools and procedures
Proven track record in Leadership role and utilizing Project Management
Proven track record in product development, design, and working closely with manufacturing
Demonstrated customer relations, problem solving, and product development skills
Ability to influence across boundaries, drive collaboration, and develop product to meet expectations
Must be well-organized, detail-oriented, with excellent oral and written communication skills

Nice To Haves

Master's degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
Proficient in Microsoft Office, Project, Minitab, and Solidworks preferred

Responsibilities

Hands-on catheter/balloon design, development, and assembly experience
Accurately predict project costs, material lead times, and delivery schedules during quoting process.
Develop bills of materials and assembly method, and provide training to technicians and assemblers.
Will work with many areas including: complex catheters, steerables, smart catheters, balloons, handle design, molding, braiding, tipping, coating, extruding.
Develop balloons (including extrusion design) and catheter subassemblies according to customer design, performance, and quality specifications; on time and within budget.
Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
Review and prepare status reports, modify schedules, and project plans as required
Keeps stakeholders, customers, and others informed of project status and/or related issues
Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related
Apply design controls from initial customer requests throughout the products life cycle
Intimately involved in developing technical documentation: protocols, including verification and validation testing, drawings, calculation and/or FMEA
Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
Address customer's issues: improve performance, appearance, and impact on end-user