Lead Packaging Engineer (Medical Devices)

Location: Hybrid in Libertyville, Illinois, US; expected to work from the Libertyville office at least 4 days per week. Travel is required based on projects.

Salary: $105,000–$150,000 yearly, plus eligibility for the hirify.global Corporate Bonus Plan.

Company

hirify.global is an independent, employee-owned healthcare products company that develops, manufactures, and markets ostomy care, continence care, and critical care products worldwide.

What you will do

• Lead and coach cross-functional projects for new product development, commercialization, and changes to existing products.
• Develop and validate sterile and non-sterile packaging and labeling systems, equipment, materials, suppliers, and laboratory equipment.
• Establish project schedules, lead cost-saving initiatives, and support continuous improvement across packaging operations.
• Ensure compliance with packaging regulations and standards, including EU MDR and FDA requirements.
• Develop and validate test methods using statistical analysis; conduct experiments, simulations, feasibility studies, prototype testing, and design iterations.
• Prepare technical documentation, reports, specifications, work instructions, and original data; present findings, support patent filings, represent hirify.global at industry events, and mentor peers.

Requirements

• Bachelor’s Degree with 8–12 years of related experience, or a Master’s Degree with a minimum of 6 years of related experience.
• Experience in medical device or FMCG packaging development and commercialisation.
• Experience with CAD, concept prototyping, and medical device sterile/non-sterile packaging system development and/or validation.
• Experience with technical writing, optimization and cost savings, design of experiments, process validation, and advanced statistical analysis.
• Experience testing packaging materials, integrity, physical properties, distribution simulation, and aging.
• Knowledge of rigid and flexible sterile barriers; fiber-based, porous, and non-porous materials; sterilization processes; form-fill-seal and heat-seal equipment; and manual and automated packaging processes.
• Knowledge of printed color specification and measurement.
• Proficiency in ISO 11607, MDR, UDI, GS1, ASTM D10 and F02, and ISTA.
• Proficiency with Qumas, SAP, ArtiosCAD, SolidWorks, CAPE, TOPS, JMP, Minitab, Microscan, PXSmartPrint, and Veeva; advanced knowledge of EU MDR, PPWR, UDI, IEC 62366, and FDA Guidance on Applying Human Factors.
• Knowledge of usability engineering for medical devices and the ability to influence packaging decisions as required.

Culture & Benefits

• Hybrid work environment with regular in-office collaboration in Libertyville.
• Medical, prescription, dental, vision, disability, life, accident, wellbeing, and voluntary benefit programs.
• Company-paid parental and caregiver leaves, statutory leaves/disability programs, paid vacation, sick days, and 11 paid holidays.
• 401(k) plan with auto-enrollment, Roth option, vesting, and eligible safe-harbor matching contributions.
• Education assistance, adoption assistance, and peer-to-peer recognition programs.