The Principal Engineer is responsible for providing engineering support in the creation and the development of new division products.
This role will use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company's strategic plan.
MAIN RESPONSIBILITIES:
Run empirical and experimental analysis.
Conceptualize new devices using material knowledge and innovative mechanical design.
Conceive and build prototypes.
Work with outside consultants, vendors, and the medical community.
Project planning: Plan, coordinate, and execute activity in support of project goals.
Identify and mitigate project risks.
Support animal and bench testing and clinical evaluations.
Support design reviews and physician visits.
Establish requirements and specifications
Test method and model development
Maintain knowledge of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
Ensure compliance with procedural and documentation requirements of SJM, FDA and ISO design controls
Technologies: Biocompatible material selection for delivery systems and implants, bioprosthetic implants, mechanical design of biocompatible metals and plastics.
Machining: Molding, Extrusion, Thermoforming, and Packaging and Sterilization
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
QUALIFICATIONS:
Education:
Major/Field of Study or Equivalent Bachelors Degree Mechanical Engineering or related
An equivalent combination of education and work experience Masters Degree