Senior Mechanical Engineer

Job Title: Senior Mechanical Engineer

Location: Jacksonville, FL
Duration: 12+months (Possibility of extension)

Purpose of job

This position has the responsibility and authority to provide a lead R&D Mechanical Engineering role in the review, remediation, test and transfer to new manufacturing facilities of existing medical devices for the ENT business.

Main Job Duties / Responsibilities

·Lead and provide guidance in the review and subsequent remediation of existing product Design History Files.

·This includes Risk Management, Requirements Traceability, Drawings/Specification Creation or Revision, development of prototypes, verification/validation activities and reports.

·Establish the test plan, device limitations and acceptance criteria and ensure the timely completion of the technical deliverables.

·Assure the protection and completion of these activities for both themselves and other members of their workgroup.

·Travel to new manufacturing site as needed to support project.

·All work must be done to comply with the Healthcare Quality System.

·Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.

·Required to interact and communicate with peers and co-workers.

·Required to spend extended periods of time on computer-based work.

·Performs other duties as assigned.

Education Qualifications

·Mechanical Engineering Bachelor’s or Master’s degree from an accredited school.

·5 or more years’ of product development experience in New Product Development or Released Product Engineering. Medical Device experience preferred, other regulated industry experience acceptable (i.e. Automotive, Industrial Machinery, Commercial Products).

Skill Qualifications

·Complete understanding and wide application of technical principles, theories and concepts in the field.

·General knowledge of other related disciplines.

·Able to review existing drawings/specification dimensions, GD&T and inspection requirements against product and quality system requirements and generate proposed changes or new drawings/specifications

·Provides technical solutions to a wide range of difficult problems.

·Solutions are imaginative, thorough and practicable and consistent with organization objectives.

·Able to lead, work and communicate effectively with other engineers, designers and suppliers to ensure products meet product and quality system requirements.

·Strong problem solving and analytical skills.