Job Description
Job Description
Key Responsibilities
- Set up test apparatus and conducts tests of production assemblies and units following methods, procedures, standards, and sequences.
- Lays out and assembles units for production equipment according to designs and specifications.
- Need to support customer resources for software/process validation on stations. The stations range from automated solutions to simple operator stations including SW and tooling.
- Adjusts and calibrate systems as needed.
- Modifies equipment by adding, removing, or altering components as defined by predetermined diagrams and sketches.
- Corrects malfunctions by adjusting or replacing parts or components as directed.
- Uses hand and small power tools, and various measuring and testing devices in performing job duties.
- May monitor and verify quality in accordance with statistical process or other control procedures.
- Perform routine and non-routine testing on products, components, or systems using automated and manual test equipment, following established procedures and engineering specifications.
- Operate, maintain, troubleshoot, calibrate, and perform preventive maintenance on test systems and equipment.
- Diagnose and isolate issues with products, or test setups, supporting root cause analysis and corrective actions, and escalating complex problems to the test engineers, or senior test technicians, as needed.
- Accurately record test data and observations in designated systems, or logs.
- Collaborate with engineering, quality, and production teams to resolve issues, implement solutions, and assist in training new technicians, or operators, on test procedures and equipment.
- Ensure compliance with safety standards, quality requirements, and company procedures, while maintaining a clean and organized work environment using workplace organization methods such as 5S.
- Corrects malfunctions by adjusting, or replacing, parts, or components, as directed.
Required Knowledge and Experience:
- Requires minimum of 8 to 10 years of relevant experience.
- Requires Engineering, or equivalent
- Requires experience in Software Validation and Controls Automation equipment handling.
- Requires knowledge of Medical Device Safety standards like, ISO 13485 and FDA 21 CFR 820
Preferred Qualifications:
- Eight, or more, years of experience in technical areas such as metallurgical, electronic, mechanical, or related disciplines.
- Strong written and verbal communication skills for effective interaction with clients, laboratory personnel, and other teams.
- Proficiency with Microsoft Office programs, including Outlook, Word, and Excel.
- Self-motivated, detail-oriented, and able to work effectively in a fast-paced team environment.
- Ability to prioritize and execute daily tasks.
- Capable of working independently with minimal supervision.
- Knowledge of LabView, MINITAB, MATLAB etc.
- Knowledge of Solid Works.
- Knowledge of 3D printing.
- Good electrical problem-solving skills.
- Good mechanical problem-solving skills.