Position Summary:
Under the general supervision of the Manufacturing Engineering Manager, the Manufacturing Engineering Technician is responsible for supporting manufacturing engineers. Duties include technical writing, action item execution, protocol & report writing, protocol execution and other technical duties as assigned. Specific responsibilities include:
Key Responsibilities:
• Writing test protocols, running tests, collecting/sorting/analyzing data, and writing final reports.
• Assist in the development of Manufacturing Processes, procedures, documentation, and fixtures
• Creating rework instructions
• Production line issue resolution
• Perform process and product validation testing
• Assist Engineering in determining new equipment requirements and needs, and incorporate the equipment into the Dymax Calibration and PM systems
• Generate CR packets, gather/generate documentation, coordinate/communicate with approval panel.
Educational Qualifications & Previous Experience
• 2-year technical degree OR relevant experience.
Professional Skills & Key Competencies:
• Excellent communication (verbal & written) and interpersonal skills
• Ability to read and understand mechanical drawings and electrical schematics.
• Detail oriented with high level of problem solving and analytical skills
• Experience with troubleshooting electromechanical systems.
• Computer skills: MS Office experience (e.g., Word, Excel, PowerPoint)
Desired / Additional Skills & Knowledge:
• Experience in a manufacturing environment in a regulated industry (medical device preferred)
• Experience with drafting/CAD/3D modeling a plus.
• Fixture design experience.
• Position requires good logic and reasoning ability. Ability to define problems and find logical solutions. Must evaluate and resolve daily issues by exercising sound judgement.
• Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies.
Any additional Information:
• Days and hours of work vary
o Standard shift is Mon-Fri 8AM-4PM
o May be required to flex hours if needed to communicate with off-shifts and divisional partners
• Travel in and outside of the US may be required to support complex project planning and collaboration.
• Ability to comply with applicable quality regulations as identified by the organization •
Last updated on Nov 2, 2023