Manufacturing Process Engineer

Position Scope/Summary:
This position will assist in performing the essential duties and responsibilities listed below as required by Tegra Medical ensuring that the customer product requirements and Tegra Medical requirements are met while meeting the requirements of the Tegra Medical quality policy and quality objectives established for the Tegra Medical ISO 13485 quality management system and by regulatory requirements.
The role of the Manufacturing Process Engineer is to assist in the planning, executing, and finalizing of product realization according to strict guidelines and deadlines, and within budget. Specific functional areas include, but are not limited to, contract review, job shop process/paperwork preparation, and technical and engineering support. The Manufacturing Process Engineer should be knowledgeable in manufacturing processes and techniques, measurement tools and methods, and engineering software. The Manufacturing Process Engineer will also assist in defining product realization requirements and assisting the production floor as needed throughout a product's life cycle.
Essential duties and responsibilities:
Ability to analyze and understand product requirements through external/internal drawings, models, work instructions and/or specifications in electronic or printed format .
Ability to use engineering CAD software packages (AutoCAD and/or SolidWorks)
Creation and maintenance of internal/external files required for product realization as applicable within the shop software (E2) and Windows environment (DMR/DHR).
Creation, modification, and maintenance of manufacturing models/drawings, gage models/drawings, overlays/underlays, reference drawings, and/or shop templates
Assist shop floor personnel in product realization in regards to manufacturing and engineering concerns and/or training
Provide customer and vendor technical support as needed
Assist in new product realization planning meetings and support the introduction of new product to the shop floor
Ability to work both independently and in a team-oriented, collaborative environment
Must be able to learn, understand, and apply new technologies
Liaise with project stakeholders on an ongoing basis
Superior written and oral communications skills
Assist planning and scheduling project timelines and milestones using appropriate tools
Assist development and delivering progress reports, proposals, requirements documentation, and presentations
Assist building, developing, and growing any business relationships vital to the success of product realization
Ability to effectively prioritize and execute tasks in a high-pressure environment is crucial
Secondary Responsibilities (Non-Essential Functions):
Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
Reacts to project adjustments and alterations promptly and efficiently
Flexible during times of change
Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments
Ability to support the organization and assist with establishing policies, procedures, and accountability measures that ensure regulatory compliance and continuous quality performance improvement
Familiarity with Machinery's Handbook, and working knowledge of GD&T fundamentals
Strong interpersonal skills
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form
Qualification Requirements:
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 and/or Experience:
Bachelor's degree preferably in Manufacturing or Mechanical Engineering, or a minimum of 4 years work experience, or equivalent combination of education and experience. Prior experience in manufacturing in the medical device or related industry is preferred. Experience with technical drawing interpretation including GD&T, and with a CAD software package is a plus.
Tegra Medical is an Equal Opportunity Employer

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