This position will be integral in determining the design of disposable, class II medical devices. It requires creativity and foresight to iterate a design for high volume production. The person in this position will also be required to design, execute and report on engineering tests, for both feasibility and product verification. The candidate must have a strong mechanical engineering background with the ability to quickly understand electro-mechanical assemblies. The lead engineer will, at times and as assigned, supervise projects and staff resources, and will have formal signature authority for designated areas in his/her area of technical expertise.
The optimum candidate has a BS in Mechanical Engineering and has at least 10 years of mechanical design experience in the Medical Device industry.
JOB / DUTIES / RESPONSIBILITIES
· Lead Engineering teams to complete and document complex development projects.
· Design iterations of the product.
· Document design development and mechanical requirement specifications.
· Design and set up feasibility tests.
· Develop Failure analysis models using simulation tools.
· Author product qualifications test and report results.
· Conduct tolerance stack up analysis on existing and new designs.
· Design test fixtures for product qualification.
· Assist in the procurement of device components that meet specification.
· Lead product design reviews.
· Provide a documents checking function and maintain documentation control prior to print release.
· Travel overnight(s) as necessary both domestically and internationally to support project goals.
Knowledge / Education
· Bachelors of Science in Mechanical Engineering
· Strong working knowledge of mechanical engineering and design
· Strong working knowledge of Computer Aided Design & Finite Element Analysis
· Minimum of 10 years work experience as a Mechanical Engineer
Skills / Competencies
· Effective verbal and written communication skills
· Ability to communicate at multiple levels of an organization
· PC skills, word processing, spreadsheet, database
· Ability to organize and judge priorities
· Ability to generate and maintain accurate records
· Experience working with medical devices.
· Familiarity with ProE, Solidworks, and Ansys applications
· Familiarity with SPC, and GD&T a plus