Senior Manufacturing Engineer - Medical Device - Danbury, CT

The Senior Manufacturing Engineer will lead advanced process development, CNC programming, and production readiness for medical device components and assemblies. This role supports both new product introduction (NPI) and continuous improvement initiatives for Class II and III medical devices-including CNC‑machined parts, catheter sub‑assemblies, and finished devices.

Client Details

My client combines cutting-edge technology with a dynamic, employee-centered culture focused on innovation, continuous improvement, and technical excellence. Their teams push the boundaries of what's possible in micro-manufacturing, partnering closely with top medical device companies to accelerate product development and bring complex medical technologies to life.

Description

• * Program and optimize CNC jobs (Milling, Multi-Axis, Wire EDM)
  * Design fixtures, tooling, and work-holding solutions
  * Troubleshoot CNC programs, machining, and equipment issues
  * Support machining of exotic/high-temp alloys
  * Estimate runtimes, costs, and work-holding for quotes
  * Create work instructions, setup sheets, and train operators
  * Serve as Manufacturing Engineering representative on NPI teams
  * Manage development/build schedules for new programs
  * Design scalable manufacturing processes and tooling
  * Transfer processes from R&D/prototyping to production
  * Provide hands-on line support and process improvements
  * Maintain documentation per ISO 13485 and QMS
  * Lead IQ/OQ/PQ, TMV, and equipment validations
  * Ensure FDA, OSHA, and customer compliance
  * Prepare engineering reports and communicate results
  * Drive Lean, Six Sigma, and structured problem-solving
  * Lead cross-functional engineering and operations efforts
  

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 in precision CNC manufacturing
* Medical device or regulated industry experience
* Strong CNC Milling & Multi-Axis expertise, programming + troubleshooting
* Proficient with CAD/CAM (SolidWorks, Mastercam, Esprit, etc.)
* Experience machining exotic alloys & HEM techniques
* Skilled in designing manufacturing processes, tooling, fixtures
* NPI/PDP experience and prototype-to-production transfers
* Analytical skills: DOE, regression, ANOVA, capability analysis
* Strong written communication (procedures, reports, protocols)
* Experience with ISO 9001/13485
* Excellent cross-functional leadership skills
* BS or MS in Mechanical, Manufacturing, Biomedical, or related field
Preferred:
* MS Engineering degree
* Interventional device assembly/packaging/sterilization experience
* Wire EDM, small-hole EDM, and turning experience
* Lean Six Sigma certification
* PMP or strong project management experience
* NPI team leadership background

Job Offer

• Competitive salary ranging from $90,000 to $125,000 annually.* Opportunity to drive innovation in advanced micro-manufacturing
• High-impact role influencing NPI, process development, and CNC strategy
• Collaborative, growth-focused engineering culture
  
• Exposure to cutting-edge technologies across medical device manufacturing
  

If you're ready to take the next step in your career as a Senior Manufacturing Engineer, apply today for immediate consideration!

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.