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 (animal and clinical studies), 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.
Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
Translates customer needs into product requirements and design specifications.
Responsible for engineering documentation.
Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
May train and/or provide work direction to technicians and entry-level engineers.
Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables.
Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.
Desired knowledge: Problem Solving, Technical and clinical knowledge, Design control methods such as Risk Analysis (dFMEA, pFMEA), Design controls, Design Validation and Verification plans, Design protocol and report generation, Product Lifecycle Process and related deliverables.
At least 5 years of experience in similar position.
Or an equivalent combination of education and experience.