R&D Engineer

Job Title:-Sr. R&D Engineer Job Location:-Bloomington, IN Long Term Contract Overview Meeting to define hiring needs for 2 R&D engineer II roles and operational support for imminent clinical-program work. Goal: fill roles ASAP . Project context: working on high-risk Class III aortic stent/delivery systems; one project is post-design-freeze with extensive non-clinical testing ( >2,000 samples referenced) and clinical trial preparation. Preferred hire split: 6-month initial engagement minimum, 1 on-site (preferred senior) and 1 fully remote/hybrid (preferred junior remote/hybrid). Project context & status Team is in the vascular/Zenith area developing large aortic stents and disposable delivery systems used to prevent aneurysm rupture. Devices are life saving Class III medical devices. One team is post-design-freeze ; current work is finishing non-clinical test evidence and compiling documentation for FDA clinical trial submission . Work is long-term and regulated; emphasis is on reliability, repeatability and thorough documentation rather than ideation/prototyping. Last steps include vendor first-article inspection and formal raw-material/part verification before activating parts into Cook's inventory. Hiring needs & profile Recruiting target: 2 R&D engineers (Engineer II) . Ideal experience level: ~3 5 years for Engineer II. Key capabilities required: highly organized , detail oriented , strong execution and documentation skills (design controls, risk management, test documentation), inventory tracking experience (lot numbers, quantities, locations). Not necessary: deep vascular device design expertise - domain knowledge helpful but core requirement is organizational/operational competency , not creative prototyping. Cultural fit: team is well-connected, collaborative , prefers reliable contributors who gain trust by being on-site; junior hires benefit from on-site exposure. Inventory, documentation & vendor expectations Inventory challenge: R&D currently uses internal/Excel-based systems and needs rigorous tracking of quantities, lot numbers, location, consumption to avoid mixing lots. First-article inspection: vendors must be verified and parts formally inspected before being activated into Cook's systems; successful inspection allows moving parts out of Excel tracking and into official inventory management. Design controls/risk management: extensive testing and traceability required to demonstrate the design meets regulatory requirements for the clinical trial submission. #J-18808-Ljbffr