Senior CNC & Validation Engineer – Medical Device Production

Torrey Holistics; Berlin (CT); On-site; USD 90,000 - 125,000; Full time

Job summary

TOMZ in Berlin, CT seeks an Advanced Manufacturing Engineer to lead CNC and validation efforts for regulated medical devices. You’ll develop robust production processes, conduct tool life analyses, lead IQ/OQ/PQ validations and reduce scrap with Lean methods.

You’ll author ECOs, train operators, and collaborate with cross‑functional teams to scale mid‑to‑high volume production. Requires a bachelor’s in engineering, 5+ years in a regulated industry, GMP/ISO 13485 knowledge, and hands‑on CAD with

Qualifications

• Bachelor’s degree in engineering or equivalent experience.
• 5+ years in a regulated medical device or aerospace environment.
• Strong knowledge of GMP and ISO 13485.

Responsibilities

• Lead CNC and validation initiatives to ensure process readiness.
• Perform tool life analyses and process capability studies.
• Draft ECOs and train operators on changes.
• Coordinate IQ, OQ, PQ with cross-functional teams.
• Drive waste reduction, quality improvements and throughput.

Skills

Detail-oriented

Strong English communication

Lean/Kaizen mindset

Root-cause analysis

Education

Bachelor's degree in engineering

Tools

SolidWorks

Microsoft Office

Adobe

PFMEA

Job description

TOMZ in Berlin, CT seeks an Advanced Manufacturing Engineer to lead CNC and validation efforts for regulated medical devices. You’ll develop robust production processes, conduct tool life analyses, lead IQ/OQ/PQ validations and reduce scrap with Lean methods.

You’ll author ECOs, train operators, and collaborate with cross‑functional teams to scale mid‑to‑high volume production. Requires a bachelor’s in engineering, 5+ years in a regulated industry, GMP/ISO 13485 knowledge, and hands‑on CAD with