Injection Molding Engineer: Lean-Driven, FDA-Ready

Nanobiosym; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Nanobiosym is seeking an Injection Molding Engineer to advance medical device manufacturing with molded and assembled parts. The role emphasizes hands-on work across multiple manufacturing steps, process validation (IQ/OQ/PQ), root-cause analysis, and continuous improvement using Lean principles.

You'll collaborate across teams to optimize molding processes, debugging, packaging, sterilization, and documentation while maintaining compliance with FDA (21 CFR 820) and ISO 13485 standards.

Qualifications

• S. or B.S. in Engineering (Plastics or Mechanical preferred).
• Six Sigma Black Belt is preferred.
• 7+ years of experience in molding, micromolding, mold flow, mold-making and tooling in manufacturing environment.
• Experience in design improvements and Solid Works/CAD.
• 7+ years of experience in diverse technical, materials, manufacturing and product design.
• Experience in statistical analysis and statistical process control.
• Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment.
• Strong written and verbal communication skills as well as documentation and organizational skills.
• Strong mechanical aptitude.
• A passion for problem solving and thrive on handling multiple priorities and working in a fast paced environment.

Responsibilities

• Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.
• Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations.
• Provide troubleshooting focus and direction for the team with details of root cause analysis.
• Utilizes Lean principles to develop creative, thorough and practical technical solutions.
• This is a hands‑on position where the requirement is to wear many hats where opportunities grow rapidly
• Utilize Lean principles to develop creative, thorough and practical technical solutions.
• Responsible for debugging, packaging and sterilization.
• Document changes to processes and equipment using change management system
• Participate in cross functional teams to improve safety, quality, efficiency and overall productivity
• Monitor and validate existing injection molding processes and molds to develop and execute continuous improvement opportunities.
• Identify risks, technical options value propositions, and champion solutions.

Skills

Strong communication

Analytical thinking

Problem solving

Lean principles

Education

Bachelor or S.B. in Engineering (Plastics or Mechanical preferred)

Tools

SolidWorks

CAD

Job description

Nanobiosym is seeking an Injection Molding Engineer to advance medical device manufacturing with molded and assembled parts. The role emphasizes hands-on work across multiple manufacturing steps, process validation (IQ/OQ/PQ), root-cause analysis, and continuous improvement using Lean principles.

You'll collaborate across teams to optimize molding processes, debugging, packaging, sterilization, and documentation while maintaining compliance with FDA (21 CFR 820) and ISO 13485 standards.