Principal Mechanical Engineers are a recognized specialist in at least one major technology. They will act as the technical authority in the area of specialty on assigned projects. They will be assigned to substantial or strategic assignments on major projects of high complexity. Assignments will often be broad in nature and require substantial experience, creativity, and ingenuity. Principal Mechanical Engineers will have critical project technical leadership responsibility and may act as Lead on most projects, including coordinating/assisting the work of engineers from other disciplines.

RESPONSIBILITIES:

• Mechanical design and evaluation of a wide range of electromechanical medical devices with potential applications in instrumentation, fluid management, motion control, pneumatics, and power transmission

• Collaborate with human factors engineers, industrial designers, usability experts, and external bodies to develop creative, clinically relevant products

• Mechanical design of plastic, metal and/or machined enclosures in accordance with applicable international standards and certification agencies

• Research, develop, design, and evaluate electromechanical components, assemblies, fixtures, and equipment; and assist in their supplier selection

• Assist in design reviews, analysis, project definition, and budget estimating

• Employ statistical techniques for manufacturability and reliability assessments

• Utilize hazard analysis, DFMEA and other tools to ensure product safety

• Prescribe and perform design feasibility, evaluation and verification testing

• Provide direction to internal and external engineering support personnel

• Interface with internal manufacturing representatives and external suppliers to define assembly processes and ensure manufacturability

• Create and validate fixtures for test and manufacturing

• Provide consulting and sustaining engineering support to manufacturing

• Research, evaluate and inform on emerging technologies and products

• Lead functional initiatives and/or manage limited scope projects

• Challenge and motivate group to ensure employee engagement and retention

• Lead analysis, review and evaluation of design alternatives

• Prepare and review design documentation and test procedures

• Lead definition, analysis and allocation of requirements

• Provide task estimates in support of projects and provides significant input to new proposals

• Provide strategic leadership for process improvement initiatives and technology innovation

• Capable of clearly defining appropriate technical approaches and solutions to the most mission-critical challenges

• Define critical project criteria to ensure project completion

• Provide mentoring, training and technical development for other engineers

• Maintain and ensure compliance with design and quality controls

• Interface with customers and business development

EDUCATION & EXPERIENCE:

• BS degree or equivalent in Mechanical Engineering or Physics

• Minimum 9-15 years experience with BS or 6-15 years experience with an MS

KNOWLEDGE & SKILLS:

• Experienced, expert level understanding of the mechanical design, drawings, prototype fabrication, design for manufacturability, production processes, and testing necessary for the development and support of new Class II/III medical devices

• Must have extensive/broad knowledge in a field of specialization

• Must be proficient at quickly solving high-complexity mechanical problems under high-visibility circumstances

• Must have detailed documentation skills

• Must have strong communication skills

• Demonstrated project planning skills

• Demonstrated track record of inspirational and effective leadership style - exhibiting good judgment

• Medical device experience preferred but not required