Advanced Manufacturing Engineer, CNC & Validation (MedTech)

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

Advanced Manufacturing Engineer, CNC & Validation (MedTech)Based in Berlin, CTWhy this role?You thrive where precision machining meets regulated excellence. At TOMZ, you’ll convert complex designs into stable, scalable processes for lifesaving medical devices—while cutting waste, boosting quality, and accelerating throughput.What you'll take onDrive down equipment/tooling downtime and scrap with hands-on floor support.Conduct tool life analyses and process capability studies to capture cost and efficiency wins.Partner with cross-functional teams to transfer products into robust, mid–high volume production.Improve processes, methods, and controls to elevate quality, reduce cost, and increase efficiency.Author and release ECOs; train operators and technicians on process changes.Create process instructions and optimize product flow, assembly practices, space, quality, and safety.Develop and qualify tools/fixtures/equipment to production readiness.Perform product and process analyses to identify improvement opportunities.Apply PFMEA and other risk tools to mitigate potential failures with defined actions.Plan and execute IQ, OQ, and PQ validations.Lead defect troubleshooting, root-cause analysis, containment, and corrective actions.Coach Engineering and Operations personnel on procedures and equipment.Disposition nonconforming material and create effective rework instructions.Lead Kaizen events and champion Lean continuous improvement.Comply with the TOMZ Quality Management System and complete other tasks as assigned.Are you someone who…Notices the small details that make a big difference?Reads prints with GD&T fluently and turns insights into action?Builds in 3D with SolidWorks and documents clearly with Microsoft Office and Adobe?Understands GMP and ISO 13485 and why they matter to patient safety?Enjoys the tempo of fast-paced medical device manufacturing?Your backgroundEducation: Bachelor’s degree in an engineering field (or equivalent experience).Experience: 5+ years in a regulated industry; medical device or aerospace contract manufacturing preferred.Preferred strengthsExcellent time management and prioritization.Self-starter who collaborates well across teams.Clear, concise communicator in English—verbally and in writing.Physical demands & work environmentAbility to bend, stoop, squat, kneel, and lift up to 20 lbs.; use team lift/mechanical assist over 20 lbs.20/20 vision (corrected or uncorrected) for sorting raw and nonconforming materials; strong dexterity for small/medium parts.Exposure to oil, grease, dust, metal particles, sparks, and sharp edges; PPE/engineering controls may be required.Regular keyboard and computer use.