Job Description
Key Responsibilities
" Coordinates, manages, and documents project goals and progress of an R&D team and recommends appropriate actions.
" Assesses the feasibility and soundness of proposed products, engineering evaluation tests, and equipment.
" Translates customer needs into product requirements and design specifications.
" Responsible for engineering documentation.
" Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
" Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment.
" Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation, and report preparation.
" Selects techniques to solve complex problems and make sound design recommendations.
" Summarizes, analyzes, and draws conclusions from complex test results.
" Designs and prepares complex reports to communicate results to technical community.
" Designs and coordinates complex engineering tests and experiments.
" Makes data-driven decisions to guide project direction and success
" Maintains a high level of organization to ensure smooth project information & task flow
" Understands the interconnectivity of project workstreams, components, and subsystems to ensure that communication flows smoothly between different workstreams
" Prioritizes documentation to support information sharing and quality control
" Demonstrates knowledge of design controls within the Client's quality system
" Works collaboratively with the team and actively contribute to our positive work culture
Qualifications:
" Minimum of 5 Years with BS, or 3 - 6 Years with MS, or 1 - 3 Years with PhD
" Mechanical or Biomedical Engineering degree or equivalent required
" Work mode: onsite
" Quality system and design control integration experience
" Strong ability to interact and collaborate with doctors in the field, preclinical studies, and in the lab
" Effective communication skills required to coordinate between cross-functional workstreams within a project
" Flexible engineer capable of adapting to varying project demands while remaining focused on the work at hand
Top Skills:
Spec setting
Test method development
Report Writing
Preferred Qualifications:
" Biomedical or anatomy experience and/or aptitude
" Medical device quality system knowledge
" Medical device product development system knowledge (PDP/TDP)
" Full PDP process experience on Class II or Class III devices
" Technical Project Management experience
Thrombectomy experience
" Setting up design controls on prints for the peening method and low pressure tester - test method development
" Finishing Liner Annealing study test planning/execution/analysis
" Support Design Controls specs and risk documentation
" Support DV testing test planning/execution/analysis/SOP alignment
" Support EDO Limit Challenge test planning/execution/analysis/SOP alignment
Quality System Requirements
" Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
" Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Client Quality Policy.
" Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Ability to pass Background and Drug Screen if Required by Client.