Senior Manufacturing Engineer (Injection Molding)

TL;DR

Senior Manufacturing Engineer (Injection Molding): Developing and optimizing injection molding processes for medical devices with an accent on bioabsorbable polymers and FDA/ISO compliance. Focus on tooling design, scientific molding principles, and comprehensive validation (IQ/OQ/PQ) to ensure high-quality medical component production.

Location: North Haven, Connecticut, USA. Must have unrestricted U.S. work authorization

Salary: $102,400 - $153,600

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical devices.

What you will do

• Establish and optimize robust injection molding processes using Scientific Molding and Design of Experiments (DOE).
• Manage process controls for bioabsorbable resins (PLA, PGA, PLGA) to minimize viscosity loss and prevent thermal degradation.
• Lead Design for Manufacturability (DFM) reviews for complex multi-cavity and micro-molding tools.
• Author and execute validation protocols (IQ/OQ/PQ) for molding machines and assemblies in compliance with FDA 21 CFR Part 820.
• Conduct root-cause investigations for production anomalies, owning NCR and CAPA execution.
• Maintain PFMEAs and design custom manufacturing fixtures.

Requirements

• Bachelor's degree with 4+ years of experience, Master's with 2+, or PhD.
• Degree in Plastics, Polymer, Manufacturing, or Mechanical Engineering.
• Unrestricted U.S. work authorization is required.
• Proven experience working with bioabsorbable or resorbable polymers (highly preferred).
• Knowledge of GD&T, PFMEA, and ISO 13485/14644 standards.

Nice to have

• 3-4 years of injection molding experience in a regulated manufacturing environment.
• Proficiency in Minitab, Statistical Process Control (SPC), and Cpk analysis.
• Experience with SolidWorks, AutoCAD, and automated machine design.
• Project management skills to lead capacity expansion and process improvement projects.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Health Savings Account (HSA) and Healthcare Flexible Spending Account.
• Tuition assistance and reimbursement programs.
• Global well-being program (Simple Steps).
• Paid time off and holidays.