Precision Manufacturing Process Engineer -- Medical Device Machining

Job Description

Job Description

Precision Manufacturing Process Engineer — Medical Device Machining

Location: Berlin, CT

A day in the life

Morning begins on the production floor, partnering with Operations to eliminate equipment and tooling interruptions before they impact delivery. You review tool life studies to uncover cost and efficiency gains, then head to the line to run capability checks that keep processes in control. Midday, you collaborate with cross‑functional teammates to transition a new product toward mid–high volume, authoring and rolling out engineering change orders and training operators on updated work instructions. In the afternoon, you facilitate a PFMEA, qualify equipment through IQ/OQ/PQ, and lead a targeted Kaizen to drive measurable improvements in quality, throughput, and cost. When defects appear, you lead root-cause investigations and implement effective containment and countermeasures. Throughout the day, you uphold the TOMZ Quality Management System.

What you will do

• Reduce and prevent equipment/tooling downtime and scrap through hands-on support.
• Run tool life and process capability studies to improve efficiency and reduce cost.
• Industrialize new products: establish and scale robust, mid–high volume processes.
• Continuously improve methods and controls for quality, cost, and throughput across sustained and new products.
• Prepare and deploy ECOs; create and deliver training to operations personnel.
• Author clear process instructions; optimize product flow, assembly methods, space usage, quality, and safety performance.
• Develop and qualify manufacturing tools and equipment.
• Analyze products and processes to identify cost, quality, and efficiency opportunities.
• Use risk tools (e.g., PFMEA) to identify risks and define corrective actions.
• Support and execute IQ, OQ, and PQ validations for processes and equipment.
• Troubleshoot defects, lead investigations to root cause, and implement durable countermeasures.
• Train Engineering and Operations team members on processes and equipment.
• Disposition nonconforming product and create rework procedures as needed.
• Lead Kaizen events and advance continuous improvement initiatives.
• Follow the TOMZ Quality Management System and perform other duties as assigned.

Qualifications

• Exceptional attention to detail.
• Fluent in interpreting drawings and specifications with GD&T.
• Proficient with SolidWorks.
• Skilled with Microsoft Office and Adobe tools.
• Strong grasp of GMP and ISO 13485 requirements.
• Hands-on experience with Lean/CI, including facilitating or participating in Kaizen events.
• Comfortable in a fast-paced medical device manufacturing setting with high output and uncompromising quality.

Education

• Bachelor’s degree in an engineering discipline or equivalent experience.

Experience

• 5+ years in a regulated industry; medical device or aerospace contract manufacturing preferred.

Preferred skills

• Strong time management and the ability to prioritize work effectively.
• Self-motivated; able to contribute independently and in teams.
• Clear, professional verbal and written communication in English.

Physical requirements

• Able to bend, stoop, squat, kneel, and lift up to 20 lbs.; team lift or mechanical assist required for items over 20 lbs.
• 20/20 vision (assisted or unassisted) for sorting raw and nonconforming materials; good manual dexterity for small to medium products.
• Exposure to oil, grease, dust, metal particles, sparks, and sharp-edged materials; PPE or engineering controls may be required.
• Frequent keyboard input and computer use.