Limb Salvage Product Development Engineer 114-S-09

Summary:  Supports product development engineering projects within area of assigned responsibility by performing the following duties personally or through cooperation with employees and supervisors from other departments.

Essential Duties and Responsibilities include the following.  Other duties may be assigned. 

Designs, invents and creates innovative designs of products to be used for replacement of large portions of the boney anatomy in a limb salvage application. Limb Salvage would include complex revisions as well as the oncology or bone cancer setting.

Reviews product design inputs with teams, and conducts product design verification/validation testing for compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements, and related specifications.

Plans and implements design verification/validation testing through the use of feasibility test requests, or verification/validation protocols and reports as necessary for product development.

Supports product development teams in developing test protocols/reports and test fixture designs. Acquires test articles and coordinates testing with R&D lab.

Coordinates preparation and completion of project deliverables, design documents, drawings and device master record packages as assigned.

Works closely with Regulatory Affairs to support, develop and implement Corrective and Preventative Action plans.

Works closely with Regulatory Affairs to develop paperwork and Design History Files as required to support FDA submissions.

Coordinates activities concerned with technical tasks, engineering design testing, design control tasks and sustaining engineering design changes as assigned.

Evaluates and approves design changes, specifications, and testing results.

Provides task status and progress reports to project team, and project team leaders.

Interfaces with manufacturing, purchasing, quality, test laboratory personnel, marketing and others to accomplish assigned tasks.

Supports product prototyping and development with CAD design and drawing creation as necessary.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

Education/Experience:

Bachelors degree in Mechanical Engineering or Biomedical Engineering from a four-year college or university; or equivalent combination of education and experience.  The following competencies are required for the position:

Medical Device industry experience preferred in either a manufacturing or product development engineering position, preferably both.

Sincere interest in the medical device business with the drive to develop new products to keep pace with new technologies. 

Self-starter requiring minimal supervision to accomplish assigned tasks.

The ability to adapt to customer, organizational, business and external influences with integrity, immediate consideration and action to meet business objectives.

The ability to design implantable devices and instrumentation to meet various design input conditions. Also the ability to read and interpret product blueprints within the design and manufacturing setting.

General knowledge of the anatomy, physiology and biomechanics of the human body is preferred.

Biomet offers excellent compensation, health care and retirement benefits. Only resumes with salary history will be considered. For confidential consideration, submit resume with salary history to: [Click Here to Email Your Resumé].

Biomet is an Equal Opportunity Employer