Senior R&D Engineer

Position Summary

The Senior R&D Engineer is responsible for managing and developing new products while interfacing with customers, vendors, and internal departments to achieve the desired product specification. The goal is to develop products, define specifications, establish reasonable timelines, and deliver high‑quality products that meet end‑user expectations. The role relies heavily on meeting deadlines, accountability, and using experience and judgment to develop products with minimal supervision.

The Senior R&D Engineer is responsible for responding to Requests for Quotes, managing quick‑turn medical device OEM projects, 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 who like to roll up their sleeves, spend time on the production floor, enjoy autonomy, and achieve quick results from their efforts.

• Hands‑on catheter/balloon design, development, and assembly
• Accurately predict project costs, material lead times, and product delivery schedules during the quoting process
• Develop bills of materials and assembly methods, and provide any needed training to technicians and assemblers
• Work with many areas including complex catheters (steerable, smart), complex shape balloons, handle design, molding, braiding, and tipping
• Develop balloons and catheter sub‑assemblies according to customer design, performance, and quality specifications; on time and within budget
• Develop products and processes that are reliable while identifying risks, developing contingency plans, and outlining deliverables and milestones
• Direct and coordinate activities to develop products and ensure progress as specifications are developed into the technical specification
• Review and prepare status reports, modify schedules, and project plans as required
• Keep stakeholders, customers, and others informed of project status and 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 product life cycle
• Write, monitor, manage, and review protocols, including verification and validation tests, ECN, SOPs, BOMs, drawings, and may include calculations and/or FMEAs as required to develop, support, or maintain technical documentation
• Intimately involved in developing protocols, including verification and validation testing, drawings, calculations and/or FMEAs to develop and support technical documentation
• Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
• Address customer issues: improve performance, appearance, and impact on end‑user

• Bachelor’s degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
• Master’s degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
• Proven balloon development experience
• 5 years’ 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 and Microsoft Project
• Experience with risk analysis 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 the end user’s expectations
• Must be well‑organized, detail‑oriented, with excellent oral and written communication skills

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262‑439‑1894.