Senior R&D Engineer - US Tech Solutions, Inc.

Purpose Statement:
This role is for an innovative technical leader to support client’s Peripheral Interventions (PI) Division within R&D. Responsible for developing new technologies, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for major segments of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. Responsibilities may include supporting existing products and/or developing new products within a cross-functional environment.
 
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 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

 
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.