Lead Sustaining R&D Engineer (Medical Devices)

Location: Hybrid in Libertyville, Illinois, US; office attendance is required at least 4 days per week.

Salary: $115,000–$155,000 yearly, plus eligibility for the hirify.global Corporate Bonus Plan.

Company

hirify.global is an independent, employee-owned healthcare products company developing, manufacturing, and marketing products for ostomy care, continence care, and critical care worldwide.

What you will do

• Provide technical leadership in identifying, designing, developing, and commercializing medical devices and supporting existing product platforms.
• Translate clinical and customer needs into device concepts, designs, prototypes, specifications, and product solutions incorporating human factors, usability, quality, and regulatory requirements.
• Lead or support concept development, feasibility assessments, prototyping, iterative design refinement, and evaluation of materials, components, suppliers, technologies, and processes.
• Develop and execute test methods, analyze experimental and performance data, and plan, perform, and document design verification and validation activities.
• Represent R&D on cross-functional teams with Quality, Regulatory, Manufacturing, Engineering, Marketing, Market Access, and other functions.
• Manage project schedules, technical and project risk analyses, technical documentation, intellectual property activities, and continuous improvement initiatives.

Requirements

• Bachelor’s degree and 8–12 years of related experience.
• Honours Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Design Engineering, or a related engineering discipline.
• Experience in medical device quality systems, design controls, and applicable regulatory standards, including EU MDR and FDA requirements.
• Experience in product design, prototype development, and verification and validation activities, preferably in medical devices or other regulated product development environments.
• Ability to communicate effectively and manage stakeholder relationships without direct authority, lead or coordinate cross-functional technical workstreams, and facilitate cross-functional workshops.
• System-level thinking, understanding of enterprise-wide impacts, and knowledge of project execution principles including planning, risk management, and cross-functional coordination.
• Proficiency with common engineering tools and software, including 3D CAD and standard business applications.
• Experience with project management in an R&D or new product development environment, supplier engagement, vendor evaluations, and external technology scouting.
• Experience integrating human factors considerations into product concept development.

Nice to have

• Master’s degree or PhD in an engineering or related technical discipline.

Culture & Benefits

• Hybrid work environment with regular in-office collaboration.
• Medical, prescription, dental, vision, disability, life, wellbeing, and voluntary benefit programs.
• Company-paid parental and caregiver leave, statutory leaves, education assistance, and adoption assistance.
• 401(k) retirement plan with auto-enrollment, Roth option, vesting, and eligible safe-harbor matching contributions.
• Paid holidays, vacation based on length of service and employment status, and sick days according to statutory requirements and employment status.
• Employee-owned culture focused on customer centricity, collaboration, innovation, accountability, continuous improvement, and performance.