Sr. Manufacturing Engineer (NPI) (Bethel)

Title: Sr. Manufacturing Engineer (NPI) Location: Greater Bethel Area, CT (100% Onsite) Employment Type: Direct Hire Status: Accepting Candidates

About the role Seeking a Senior Manufacturing Engineer to support

New Product Introduction (NPI)

initiatives within a regulated medical device manufacturing environment. This role focuses on engineering scalable manufacturing processes, supporting product launches, and leading validation activities to ensure production readiness.

Key Responsibilities Serve as Manufacturing Engineering lead on

NPI programs

from concept through production transfer. Design and optimize scalable manufacturing processes, tooling, and fixtures. Program and troubleshoot

CNC machining operations

(Milling, Multi-Axis, Wire EDM). Lead

IQ/OQ/PQ validation , TMV studies, and equipment commissioning activities. Create and maintain manufacturing documentation in compliance with

ISO 13485

and internal QMS. Drive

continuous improvement

initiatives to enhance quality, safety, and efficiency.

Qualifications 5+ years of Manufacturing Engineering experience (flexible to 3–4 years). Hands-on experience with

IQ/OQ/PQ validation

in regulated manufacturing. Strong exposure to

CNC programming

(G-code/M-code preferred). Experience supporting high-volume manufacturing processes. Knowledge of ISO 13485 and structured QMS environments. Must be able to work onsite 100%.