Applications Engineer

Job Summary

This position requires the employee to work onsite at the assigned company location as an essential function of the role. The role of the Applications Engineer is to plan, execute, and successfully complete projects within established deadlines and budget constraints, while supporting the Tegra Medical Quality Policy, Quality Objectives, the ISO 13485 Quality Management System, and all applicable regulatory requirements.

Role and Responsibilities

• Apply common sense understanding to carry out instructions furnished in written, oral or diagram form
• Work both independently and in a team-oriented, collaborative environment
• Use common measuring devices such as micrometers, calipers, and optical comparator
• Read blueprints, drawings, and printed documents
• Create or modify standard CNC programs
• Use CAD/CAM software
• Reference Machinery's Handbook and apply GD&T fundamentals
• Support operators with training and guidance during the set-up process
• Provide guidance on manufacturing model, drawings, overlays and templates
• Support production and quality through troubleshooting and analysis of CNC processes
• Contribute to process improvement activities on legacy products
• Participate in the New Product Quotation and Design for Manufacturing process
• Aid in New Product Introduction and support the developmental process on the shop floor
• Liaise between Engineering, Quality and Operations to communicate objectives and priorities
• Communicate project updates to team members in a timely and clear fashion
• Participate in complaint management and conduct root cause analysis
• Perform risk assessment to help mitigate future problems
• Conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
• Proactively manage changes in project scope, identify potential crises, and devise contingency plans
• Perform non-routine tasks assigned by supervisor
• Foster technical exchange between Hernando and the SFS sites
• Promote a healthy work environment that fosters growth in employees
• Support the organization and assist with establishing policies, procedures, and accountability measures that ensure regulatory compliance and continuous quality performance improvement

Qualifications

• Strong familiarity with project management software
• Database and operating systems experience with Quality Mgmt., SPC, others
• Demonstrated experience in personnel management
• Technically competent with various software programs such as Microsoft Office and Minitab
• Experience working both independently and in a team-oriented, collaborative environment
• Ability to 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 read communication styles of team members and contractors from a broad spectrum of disciplines
• Persuasive, encouraging, and motivating
• Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments
• Ability to defuse tension among project team
• Ability to bring project to successful completion through political sensitivity
• Strong written and oral communication skills
• Strong interpersonal skills
• Adept at conducting research into project-related issues and products
• Must be able to learn, understand, and apply new technologies
• Customer service skills an asset
• Ability to effectively prioritize and execute tasks in a high-pressure environment

Education Requirements

Bachelor's degree preferably in a technical field and a minimum of six years of work experience, or equivalent combination of education and experience. Prior experience in Quality Assurance, regulatory compliance, and project management in the medical device industry or related industry is preferred. Experience in performing validation and qualification of equipment, processes and software in the medical device or related industry. Experience with ISO 13485 standard and/or FDA Quality System Regulations is a plus.

Physical Requirements

• Frequent performing repetitive work
• Occasional lifting (max. 40 lbs.)
• Occasional carrying (max. 40 lbs.)
• Subject to physical hazards from moving equipment and machine parts
• Constant safety glasses
• Constant full PPE
• Frequent standing
• Occasional sitting, walking, pushing, pulling, reaching