Tech 1, Mechanical Engineering

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