Senior R&D Engineer

Req #: 34847

 Job Description:

 Purpose/Role Statement

Develops new complex surgical instruments with minimal supervision.    Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects.
Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. 
 
Key Responsibilities
•               Understanding, developing, characterizing and documenting complex
            mechanical designs for surgical devices.
•               Consistently generates innovative and unique solutions to market needs and submits idea disclosures.  Work is expected to result in the development of new products and processes.
•               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.
•               Summarizes, analyzes, and draws conclusions from complex test results.
•               Designs and coordinates and documents complex engineering tests and experiments.
•               Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
•               Interfaces with Physicians/ Lab personnel to obtain feedback on concepts and performance of new devices.
•               Translates customer needs into product requirements and design specifications.
•               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 knowledge of FDA design control requirements through coaching and delivery of high quality, high impact deliverables.
•               Obtain and analyze technical data and apply the appropriate statistical tools and methodologies (i.e. Six Sigma, DMAIC and DOE)
•               Constructively challenges team mates to anticipate technical problems and paths to resolution
•               Demonstrate knowledge of design controls for class II medical devices
 
Quality Systems Duties and Responsibilities
Build Quality into all aspects of their work by maintaining compliance to all quality requirements
 
Qualifications
•               Typical minimum education/years experience: BS in Engineering/Technical Field; 5+ years experience (3+ years with MS; 1-3 years experience with a Ph.D.)
•   Experience with surgical/laparoscopic tool development is required
•               PDM Wind chill experience a plus
•               Demonstrated competence with solid modeling (Solid Works preferred)
•               Competent in the application of statistical analysis software (Minitab preferred)
•               Working knowledge of machine and hand tools.
 

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