Duties and Responsibilities: Support the engineering team in development of new catheter-based medical devices and improvement of manufacturing processes in accordance with FDA and international regulations.
• Support day-to-day engineering activities including hands on laboratory and manufacturing support.
• Assemble medical device prototypes for product evaluation and testing.
• Perform testing using standard laboratory and inspection equipment (e.g. force testers, calipers, flow models, gauges, etc.)
• Build tools and fixtures utilizing experience with common shop tools.
• Support installation, troubleshooting, and maintenance of R&D equipment.
• Execute work according to approved procedures and provide feedback to update or generate new procedures as needed.
• Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations (21 CFR 820) and ISO 13485 requirements.
• Assure individual and group safety when conducting all activities.
• Maintain clear and effective communication with supervisors and cross-functional team members.

Education & Certifications:
• High school diploma or GED required
• Technical degree programs/certifications desired

Work Experience:
• 1-3 years experience working in a lab or medical device manufacturing environment.

Knowledge, Skills & Abilities:
• Mechanical aptitude
• Experience with physical and mechanical testing. ISO and ASTM testing experience preferred.
• Ability to read and interpret engineering drawings.
• Basic knowledge/capability of SolidWorks is preferred.
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices

Physical Requirements:
• Able to use a microscope and operate machinery.
• Must be able to lift and carry up to 40 lbs.