Medical Device - Sr. Manufacturing Engineer - Danbury, CT

This Senior Manufacturing Engineer will own advanced CNC machining process development, new product introduction (NPI), and production readiness for precision medical device components and assemblies. The role blends hands-on manufacturing engineering, CNC programming, validation, cross-functional leadership, and continuous improvement to support both legacy and new product lines.

Client Details

A rapidly growing global medical device manufacturer specializing in micro‑manufacturing, advanced engineering, and product development. The organization partners with top medical OEMs and is known for its cutting‑edge technologies, strong employee‑centric culture, and commitment to innovation in Class II and III device production.

Description

• Program and optimize CNC machining processes (milling, multi‑axis, wire EDM).
• Design tooling, fixtures, and workholding solutions for repeatable, high‑efficiency manufacturing.
• Troubleshoot CNC programs, machining performance, tooling, and equipment issues.
• Support NPI from concept through production transfer, working closely with customers and internal teams.
• Develop scalable production processes, build schedules, and documentation compliant with ISO 13485.
• Lead IQ/OQ/PQ, TMV, equipment qualification, and validation reporting.
• Implement Lean and Six Sigma methodologies to improve cycle time, yield, and operational efficiency.
• Provide hands-on floor support and train operators on setup, operation, and best practices.

Profile

• 5+ years of CNC machining/manufacturing experience, ideally in medical device or a regulated industry.
• Strong CNC programming background (Mastercam, SolidWorks, Esprit, or similar).
• Familiarity with exotic/high‑temp alloys and high‑efficiency machining principles.
• Experience developing processes, tooling, and fixtures for regulated production environments.
• Skilled in NPI, design transfer, and cross-functional project leadership.
• Knowledge of DOE, regression, ANOVA, and process capability analysis.
• Comfortable generating validation protocols, procedures, and manufacturing documentation.
• Engineering degree in Mechanical, Manufacturing, Biomedical, or related discipline.

Job Offer

• Competitive compensation and benefits package.
• Opportunity to lead high-impact engineering initiatives in a fast-growing medical manufacturing environment.
• Exposure to cutting-edge micro‑manufacturing technologies and complex medical device programs.
• Collaborative, dynamic culture focused on innovation, quality, and continuous improvement.
• Career growth potential across engineering, operations, and technical leadership tracks.

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.