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.