The Mechanical Engineering Technician will support engineering during the assembly and rework of mechanical systems. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
- Author and/or perform verification test plans on various disposable devices.
- May design and manufacture custom fixtures.
- Assist engineers by performing analysis, testing, and support of machines, tools, equipment, and mechanical systems.
- Troubleshoot product designs and suggest or implement improvements.
- Repair, rework, or modify mechanical assemblies to meet operational specifications and tolerances. Assemble and/or rework of production mechanical subsystems.
- Support assembly and rework of engineering prototypes during product development.
- Assist engineers with fabricating and assembling mechanical prototype models from blueprints, schematics, or sketches.
- Conduct functional and operational tests to evaluate performance and reliability of prototype or production models.
- Work with engineers to perform root cause and failure analysis as required. May provide support to manufacturing to ensure product is created to engineering specifications.
- Minimum of 3 years’ experience working in medical device industry; disposable device experience desired.
- 2 year degree or equivalent experience
- Knowledge of FDA, GMP, and ISO 13485; any experience with QSR implementation is desired, but not required.
- Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
- Strong attention to detail including analytical and problem-solving skills.
- Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.
- Advanced computer skills and working knowledge of Microsoft Office applications.
- Previous start-up experience, a plus, but not required.
- Light work, exerting up to 20 lbs. of force or less.
- Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
- Requires fingering, repetitive motion, talking and hearing.
- Significant work pace & pressure due to deadlines.
To apply, please submit your resume and cover letter documents below.
|Position reports to:||Engineering Manager|