The Panther Group
NPI Technician
The Panther Group, Westborough, MA, United States
The Panther Group has an immediate need for a New Product Introduction Technician in the Westborough, MA area. The NPI Technician is primarily responsible for assembling complex medical devices for projects in Phase 3 (Design Verification) and Phase 4 (Clinicals). They will provide oversight of operators in meeting quality specifications on NPI phase projects. Assist project team in transitioning Design and Development projects to production in a small team and collaborative environment. Communicate directly with project lead and engineers on build status and timeline.
Responsibilities:Efficiently, effectively, and consistently assemble complex medical devices
Produce product with minimal scrap and minimal to no engineering rework
Accurately and promptly fill out quality assurance records
Ability to identify non-conforming and/or reject assemblies and communicate source of issues to project team
Conduct incoming, in process and final inspection of components, assemblies and finished goods
Identify areas for process improvements of complex medical devices to project team
Support training of operators on qualified assembly tasks
Participate in equipment setup, build preparation, and line breakdown as applicable
Assist in inventory management with tasks such as kitting and cleaning of components
Maintain a clean and organized workstation during project builds
Enforce and abide by Controlled Environment Room (CER) procedures and best practices
Complete tasks that support the upkeep and maintenance of the CER(s) and broader facilities
Other duties as assigned
Required Qualifications:High School diploma or Equivalent
Ability to adapt quickly and positively to changing priorities and processes
Ability to come up to speed on new processes quickly
Ability to lead a wide range of manufacturing tasks with minimal repetition and varying complexity
Ability to work under minimal to no supervision
Ability to effectively use basic measurement tools including but not limited to rulers, calipers, micrometers, and pin gauges
Ability to effectively use basic hand tools and cutting instruments including but not limited to microscopes and standard razor blades
Catheter assembly experience required.
Ability to read, comprehend and follow complex manufacturing work instructions
Preferred Qualifications:Experience with laser welding processes and techniques
Experience with catheter processing equipment including hot boxes, laminators, split die bonders and tipping machines
Experience working in a Controlled Environment Room (CER)
Familiarity with ISO Quality Systems particularly in medical device development and manufacturing
Ability to read and understand engineering drawings
Ability to create job related records for quality purposes
Physical Demands:Standing and walking for short periods of time.
Ability to use a microscope, including manipulating small objects under a microscope for long periods of time.