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Job Summary:

The Principal Engineer position is expected to serve in an organizational technical leadership role through their involvement with key elements of the business utilizing their technical and clinical knowledge and experience. The Principal Engineer position is responsible for providing technological leadership and insight into the development of new production processes, procedures and technologies, the development of technology and product roadmaps, and the continuous development of a multi-year new product development pipeline for the TIS business.

In addition to the above, the Principal Engineer position is accountable for providing sound technical leadership to new product and process development activities by providing technical direction, insight and coaching to project technical leaders and process leaders in solving complex product/process design, development, and production issues. The Principal Engineer is expected to participate in solving the most complex technical and development issues requiring resolution.This position will also serve as the Subject Matter Expert for the Design for Excellence (DFX) aspect of the processes and design. Depending on the department, the Principal Engineer may have direct reports with managerial responsibilities or will oversee project teams with overall responsibilities for complex projects.

Job Details:

• Provide organizational engineering leadership in the design, development, and qualification of products, processes, and process equipment in accordance with TMC QA101 Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements.
• Provide manufacturability insight and guidance to the engineering organization for the design and development of new products to facilitate the development of viable production processes for the products under development.
• Contribute to department strategies, management direction and initiatives, and provide high level technical support in management and executive meetings.
• Provide complex technical strategy for projects to design, develop, and qualify new processes for manufacturing new products or improving existing products/processes.
• Provide engineering leadership and technical expertise to solve complex technical issues on projects and process development. Assist the Technical Leader on a project(s) to lead and implement the technical aspects of large projects.
• Provide technical leadership to the performance of formal process validations to ensure their compliance to validation protocols.
• As required, serve as a Problem Solver to product and process issues by providing technical leadership to understanding the technical issues and applying the proper engineering tools and techniques for their resolution and implementation of any required process modifications.
• Develop and maintain effective working relationships and proactively communicate with senior engineers and leaders in D&T, Manufacturing Engineering, Quality Assurance, and Manufacturing within TMC to partner in the development/transfer of manufacturing processes within the Elkton facility.
• Participate in and contribute to project team meetings, Design Reviews, and other formal project reviews.
• Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition.
• Prepare and present technical presentations to all levels of personnel in a manner that effectively communicates technical activities in an understandable way to the target audience.
• Performs other job-related duties assigned.

Position Requirements:

Knowledge, Skills and Abilities (KSAs):

• Extensive technical leadership and experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements.
• Experience in the application of Design for Six Sigma (DFSS), Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools.
• Demonstrated understanding of the cross-functional interactions needed for the development of new products and manufacturing processes within FDA design control guidelines.
• Organizationally recognized exceptional analytical and problem solving skills; ability to solve the most complex problems and implement solutions or processes.
• Demonstrated ability to create a process development strategy and technical approach for a large medical device project and coordinate with applicable cross-functional leaders to gain alignment.
• Demonstrated technical leadership in the design, development and implementation through production qualification of a new or novel medical device production process.
• Strong communications skills. Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to the FDA.
• Effective use of MS Office Suite.

Background Experience:

• BS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college with 15 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field; advanced degree in Engineering preferred.
• Six Sigma Black Belt certification is desirable.