Sr. Staff Engineer (MedTech)

TL;DR

Sr. Staff Engineer (MedTech): Developing and optimizing medical products and industrial manufacturing methods for a B2B MedTech and Pharma portfolio with an accent on the full product lifecycle from concept through validation. Focus on ensuring strict compliance with FDA and ISO standards and optimizing manufacturing efficiency and layout.

Location: Onsite in Allentown, Pennsylvania, United States

Salary: $94,800 - $104,800

Company

hirify.global is a global leader in infusion therapy and pain management, dedicated to eliminating preventable treatment errors and enhancing safety in healthcare.

What you will do

• Own the full product lifecycle from concept through validation and ongoing support.
• Develop and improve industrial manufacturing methods, fabrication processes, tooling, and assembly methods.
• Analyze workforce utilization and design equipment and workspace layouts for maximum efficiency.
• Estimate production times, staffing requirements, and related costs to support management decisions.
• Collaborate with vendors to determine product specifications and arrange equipment and material purchases.
• Evaluate products based on rigorous specifications and quality standards.

Requirements

• Bachelor's degree in Engineering.
• 6+ years of experience in an engineering field within a regulated environment.
• Proficiency in CAD, specifically SolidWorks.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Must be able to work onsite in Allentown, PA.

Culture & Benefits

• Comprehensive healthcare package.
• 401(k) retirement plan.
• Tuition reimbursement.
• Culture of "Sharing Expertise" focused on continuous improvement of healthcare products.