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.
