Mechanical Engineering Technician

Basic Function

We are seeking a high caliber Mechanical Engineering Technician. The technician will be tasked primarily with supporting engineering during the assembly and rework of the mechanical systems of a novel medical device. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

• Support assembly and rework of engineering prototypes during product development.
• Assemble and/or rework of production mechanical subsystems.
• Author and/or perform verification test plans on various disposable devices.
• May design and manufacture custom fixtures.

Qualifications

• Minimum of 5 years’ experience working in medical device industry; disposable device experience desired.
• 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.
• Familiarity with catheter construction techniques and processes including braiding, reflowing, thermoforming, injection molding, and adhesive bonding.
• Experience assembling small parts with the aid of a microscope.

Working Conditions

• 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.