Senior Manufacturing Engineer - Medical Device - Newtown, CT
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Overview
Job Description
This Senior Manufacturing Engineer role supports advanced manufacturing for Class II and III medical devices, including CNC‑machined components, catheter subassemblies, and complete device builds.
Client Details
Our client is a global medical device manufacturing organization specializing in micro‑manufacturing, advanced engineering, prototyping, and product development.
Description
This Senior Manufacturing Engineer will:
- Program, optimize, and troubleshoot CNC Milling, Multi‑Axis, and Wire EDM operations.
- Design fixtures, tooling, and work‑holding solutions for efficient, repeatable production.
- Support machining of exotic/high‑temperature alloys and apply high‑efficiency machining methods.
- Create work instructions, setup sheets, and operator training materials.
- Lead manufacturing process development for NPI, from concept through production transfer.
- Manage build schedules, coordinate directly with customers, and ensure production readiness.
- Provide hands‑on line support to solve equipment, process, and workflow issues.
- Maintain ISO 13485‑compliant manufacturing documentation and lead IQ/OQ/PQ validations.
- Ensure compliance with FDA, OSHA, customer specs, and regulatory guidelines.
- Implement Lean/Six Sigma methods to reduce cost, cycle time, and defects.
- Drive cross‑functional collaboration and provide technical leadership across teams
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Profile
A Successful Senior Manufacturing Engineer should have:
- 5+ years of precision CNC manufacturing experience.
- Strong CNC Milling & Multi‑Axis machining background (programming, setup, troubleshooting).
- CAD/CAM proficiency (SolidWorks, Mastercam, Esprit, etc.).
- Experience with medical device or regulated manufacturing environments.
- Skilled in DOE, regression, ANOVA, capability analysis, and process development.
- Strong communication, documentation, and cross‑functional leadership skills.
- BS or MS in Mechanical, Manufacturing, Biomedical, or related engineering discipline
Job Offer
- Competitive salary and benefits.
- Opportunity to shape advanced manufacturing for high‑growth medical device programs.
- Fast‑paced environment with strong emphasis on innovation and continuous improvement.
- Cross‑functional leadership exposure and advancement potential.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
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