Job Summary
This position requires the employee to work onsite at the assigned company location as an essential function of the role. This position has the responsibility and authority to perform the essential duties and responsibilities listed below, as required by Tegra Medical, while ensuring that customer product requirements and Tegra Medical requirements are met. The position is also responsible for supporting the requirements of the Tegra Medical Quality Policy, Quality Objectives, the ISO 13485 Quality Management System, and all applicable regulatory requirements. The role of the Applications Engineer is to plan, execute, and successfully complete projects within established deadlines and budget constraints.
Role and Responsibilities
- Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
- Ability to work both independently and in a team-oriented, collaborative environment.
- Proficiency in the use of common measuring devices; Micrometers, calipers, Optical Comparator etc.
- Ability to read blue prints, drawings, and printed documents.
- Create or modify standard CNC programs.
- Proficiency in CAD/CAM software.
- Familiarity with Machinery’s Handbook, and working knowledge of GD&T fundamentals.
- Support operators with training and guidance during the set-up process.
- Providing guidance on manufacturing model, drawings, overlays & 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 activities related to New Product Introduction and provide support in the developmental process on the shop floor.
- Liaise between Engineering, Quality and Operations to help accurately communicate objectives and priorities .
- Effectively communicate project updates to team members in a timely and clear fashion.
- Actively participates in complaint management and conducts 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 task assigned by supervisor.
- Foster technical exchange between Hernando and the SFS sites.
- Promote a healthy work environment that forester growth in our 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, Minitab, etc…]
- Experience at working both independently and in a team-oriented, collaborative environment is essential.
- 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 read communication styles of team members and contractors who come 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, should it arise.
- 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 is crucial.
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.
Skills Required
- Bachelor's degree, preferably in a technical field, or equivalent combination of education and experience
- Minimum six years of work experience
- Ability to create or modify standard CNC programs
- Proficiency with CAD/CAM software
- Ability to use micrometers, calipers, optical comparators, and other measuring devices
- Ability to read blueprints, drawings, and technical documents
- Working knowledge of GD&T fundamentals
- Project management software experience
- Database and operating systems experience, including quality management and SPC systems
- Personnel management experience
- Microsoft Office and Minitab proficiency
- Prior experience in quality assurance, regulatory compliance, and project management in the medical device or related industry
- Experience validating and qualifying equipment, processes, and software in the medical device or related industry
- Experience with ISO 13485 and FDA Quality System Regulations
- Strong written, oral, interpersonal, analytical, problem-solving, and project coordination skills
What We Do
Tegra Medical is an end-to-end contract manufacturing solutions provider, known as the company “where medical devices come to life.” Our customers look to us to manufacture everything from complex components to finished devices – from the sharp “business end” to the molded plastic handle – including assembly, sterilization and packaging. Our headquarters is in Franklin, Massachusetts and we have manufacturing locations in Massachusetts, Mississippi, Costa Rica, Europe, and Asia. We are ISO 13485 and FDA registered. Tegra Medical is a member of SFS. We often have open job positions for skilled manufacturing positions. Please see https://www.tegramedical.com/careers/ for our latest job openings.
