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).

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.

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 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.