Injection Molding Process Engineer – Quality Focus

Aptyx; Torrington (CT); On-site; USD 85,000 - 120,000; Full time

Job summary

Aptyx seeks a Process Engineer - Quality Focus to lead injection molding and secondary operations in a regulated medical device environment. You will own processes, drive capability, and ensure product quality and long-term robustness on the production floor.

You will validate processes (IQ/OQ/PQ), develop documentation, and support NPI and continuous improvement with cross-functional teams. Emphasis on data-driven problem-solving, CAPA, and audits.

Qualifications

• Bachelor's degree in a related engineering discipline.
• Minimum 3–7 years in manufacturing/ process engineering.
• Experience in plastic injection molding and regulated environments.
• Medical device manufacturing experience preferred.

Responsibilities

• Own and optimize injection molding and secondary manufacturing processes to ensure robustness and product quality.
• Lead IQ/OQ/PQ validations and maintain technical manufacturing documentation (Process Flows, PFMEAs, Control Plans, work instructions).
• Support change control activities related to materials, tooling, equipment, and processes.
• Partner with Quality, Production, Tooling, Maintenance, Engineering and PM to support daily manufacturing operations, NPI, and improvements.
• Lead continuous improvement initiatives (yield, scrap, Cp/Cpk, cycle time; use Lean/Six Sigma, DMAIC, 8D).
• Provide technical guidance and training to operators and technicians; support internal audits.

Skills

Injection molding

Process validation

SPC & Cp/Cpk

PFMEAs & Control Plans

Root cause analysis

Lean & Six Sigma

Education

Bachelor's degree in engineering

Tools

Microsoft Office

Job description

Aptyx seeks a Process Engineer - Quality Focus to lead injection molding and secondary operations in a regulated medical device environment. You will own processes, drive capability, and ensure product quality and long-term robustness on the production floor.

You will validate processes (IQ/OQ/PQ), develop documentation, and support NPI and continuous improvement with cross-functional teams. Emphasis on data-driven problem-solving, CAPA, and audits.