Staff Engineer, Packaging (Medical Devices)

Location: Wayne, New Jersey, United States; site-based with 1–2 days working from home

Salary: $120,000–$145,000 per year plus a bonus targeted at 10%

Company

hirify.global develops medical technology and healthcare solutions for cardiovascular procedures, intensive care, operating rooms, sterile reprocessing, and life science institutions, with products sold in more than 135 countries.

What you will do

• Act as the packaging engineering subject matter expert for sterile and non-sterile medical device packaging systems.
• Lead packaging strategy, design, development, validation, commercialization, and lifecycle management for new product and sustaining engineering programs.
• Design sterile barrier systems and protective packaging compliant with ISO 11607 and global medical device regulations.
• Develop validation strategies and protocols covering packaging processes, package integrity, transportation simulation, aging studies, and labeling systems.
• Partner with Manufacturing, Quality, Regulatory Affairs, Supply Chain, Operations, and suppliers to resolve non-conformances, manage changes, and improve process capability.
• Mentor engineers, lead complex cross-functional initiatives, and present technical recommendations to senior leadership.

Requirements

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, or a related technical discipline.
• At least 8 years of progressively responsible packaging engineering experience, preferably in medical devices, pharmaceuticals, or regulated healthcare.
• Experience leading complex packaging development and validation programs from concept through commercialization.
• Expertise in ISO 11607 Parts 1 and 2, ISO 13485, ASTM packaging standards, sterile barrier systems, cleanroom packaging, labeling, and UDI requirements.
• Knowledge of Design Controls, ISO 14971 risk management, CAPA, change control, complaint investigations, and validation requirements.
• Advanced statistical analysis, process capability analysis, DOE, root-cause investigation, and structured problem-solving skills.

Nice to have

• Master’s degree in engineering or packaging engineering.
• Certified Packaging Professional certification or equivalent.
• Experience with Class II and Class III medical devices and global manufacturing environments.
• Experience leading or mentoring engineering teams.
• Proficiency with Minitab, SAP or PLM systems, labeling systems, SolidWorks, AutoCAD, TOPS, CAPE, and Microsoft Office.

Culture & Benefits

• Health, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off, parental and caregiver leave.
• Life insurance, short- and long-term disability benefits, and health and dependent care flexible spending accounts.
• Wellness initiatives, health assistance resources, commuter benefits, and tuition reimbursement.