OEM R&D; Sr. Staff Engineer (MedTech)

Location: Onsite in Allentown, Pennsylvania, United States

Salary: $94,800–$104,800 per year

Company

hirify.global develops, manufactures, and markets medical products and services for infusion therapy, pain management, nutrition, pharmacy compounding, ostomy and wound care, and dialysis.

What you will do

• Own the product lifecycle from concept through validation and ongoing product support.
• Develop, evaluate, and improve industrial manufacturing methods, tooling, equipment, assembly methods, and quality controls.
• Analyze workforce utilization, space requirements, workflows, and equipment layouts to improve efficiency.
• Estimate production times, staffing requirements, and related costs for management decisions.
• Communicate manufacturing capabilities and production schedules to support production processes.
• Coordinate with vendors on product specifications, equipment, materials, parts, and quality evaluation.

Requirements

• Bachelor’s degree in engineering.
• 6+ years of related engineering experience in a regulated environment.
• Experience leading complex projects and influencing technical and business outcomes.
• CAD proficiency; SolidWorks is preferred.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 is required for regulated product development and risk management.
• Regular and predictable attendance and the ability to occasionally lift or move up to 20 pounds.

Nice to have

• Applicable industry or professional certification.
• SolidWorks experience.

Culture & Benefits

• Cross-functional collaboration with customers, vendors, clinicians, and global industry partners.
• Healthcare benefits.
• 401(k) plan.
• Tuition reimbursement.
• Continuous improvement through the Sharing Expertise initiative.