Staff Engineer

The client is a Medical Device maker/supplier that has been at the leading edge of interventional vascular medicine and electrophysiology since the 1960’s. From their involvement in catheters to PTCA, to coronary implants and pharmaceuticals, this leader in coronary medicine reflects the rapid changing landscape in this treatment area. If your career in Med-Dev engineering needs the fast-paced, high profile development/commercialization challenge, this is your next employer.

Our client is located in Southern FLORIDA.

The position of Staff Engineer includes responsibilities in design and new product commercialization activities around Drug Eluting Stent (DES) Programs for cardiac applications. The primary focus is on the design and technical elements associated with integrating the stent and the delivery system.
Essential responsibilities –

applies diversified knowledge of engineering principles in broad range of assignments

capable of leading small Teams and/or acting as an individual technical contributor

identifies potential technical solutions for complex problems

anticipates technical issues that may not have direct precedence

uses internal and external sources for information and applies appropriate requirements in the definition and execution of activities

drives change to completion ensuring that best practices are self-sustaining by leadership, reputation, and processes

overcomes obstacles, anticipates risk, and develops contingency plans (e.g. FMEA)

identifies either best practice or technologies to enhance probability of success

may direct Engineers, arrange appropriate assignments, formal training, and coaching to foster learning and development

creates and drives complex project plans

systematically reduces complex situations, problems, or processes into component parts for analysis and/or to validate hypotheses

recognizes and understands interdependencies affecting the design or output

takes initiative in proposing new innovations, devising strategy or devising tactics

drives the use of design/process excellence tools to new & different ways of doing business

works collaboratively between functional/technical groups when required

reviews, approves, and executes Installation, Operational, and Performance Qualifications (IQ,OQ,PQ) for various equipment and systems

writes, reviews, and approves documentation related to the development and commercialization

performs Design Validations, Design Verifications, Product Descriptions, Hazard Analysis, technical reports, etc.




Experience –

BS or MS Engineering degree

5-10 years of related engineering experience, preferably in an FDA regulated environment

strong analytical and communications skills are critical

new product development and commercialization experience of medical devices is desirable (Class III/PMA medical devices preferred)

knowledge of ISO, cGMP and Quality Systems Regulations (QSR) is beneficial

a certification in Process and/or Design Excellence (Green Belt or Black Belt) is desired

previous supervisory experience preferred