NextPhase Medical Devices LLC is a fast growing, contract manufacturer of single- use disposable medical devices. Headquartered in Waldwick, NJ, we also have manufacturing facilities in Rochester, NH and Tijuana, Mexico.
The Senior Project Engineering Technician works directly with engineering staff to execute of complex tasks in support of customer projects, cost savings initiatives, process development and testing of complex medical devices. They also aid in the development of delicate assembly operations with complex equipment and microscopy.
- Develop detailed instructions under process development that may then be translated into working assembly procedures.
- Assist in the training of operators, working from drawings, specifications and assembly procedures.
- Partner with the Project Engineers to ensure deliverables to the customer are completed on time and on budget.
- Assist Project Engineers in the design of basic fixtures for assembly, i.e., holding fixtures, cutters, go/no-go gauges, etc.
- Install and maintain various assembly and process equipment used in the assembly of disposable medical devices, including but not limited to UV bonding equipment, adhesive dispensers, leak testers, solvent bond dispensers and ultrasonic welding equipment.
- Evaluate assembly steps and identify opportunities for use of fixtures and hand tools to improve throughput and reduce scrap.
- Develop equipment files and create comprehensive preventive maintenance procedures for assembly equipment.
- Conduct First Article Inspections of components used in the assembly of medical devices using tools such as micrometers, calipers, temperature pyrometers, pin gauges, CMM.
- Run experimentation under protocol and collect attribute and variable data using basic math skills.
Skills & Experience Required:
- 7+ years’ experience of increasing skill level in assembly, working with mechanical equipment in the medical device or other highly regulated industry.
- Associate technical degree preferred.
- Sound mechanical/electrical skills and an understanding of basic machinery principles.
- Familiarity working in a lab or development environment.
- Skill working under a microscope, performing delicate procedures involving high precision and dexterity.
- Prior experience working under ISO 13485:2016, ISO 14971: 2007 and 21CFR Section 820 (FDA QSR).
- Basic skills in Microsoft Word, Excel and Outlook
- CAD software (SolidWorks) experience preferred.