Lead R&D Engineer (Medical Devices)

TL;DR

Lead R&D Engineer (Medical Devices): Providing technical leadership in the design, development, and commercialization of medical devices with an accent on product lifecycle management and sustaining engineering. Focus on translating clinical needs into compliant designs, executing verification and validation activities, and collaborating across cross-functional teams to ensure high-quality, customer-focused solutions.

Location: Must be based in Libertyville, IL or Ballina, Ireland. This is a hybrid role requiring 4 days per week in the office.

Salary: $110,000 - $155,000 yearly.

Company

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

What you will do

• Represent R&D on cross-functional product development and commercialization teams.
• Translate clinical and customer needs into device concepts, designs, and prototypes.
• Develop and execute test methods to characterize product performance and functionality.
• Plan and document design verification and validation activities in compliance with regulatory standards.
• Manage project schedules, conduct risk analyses, and ensure timely delivery of project milestones.
• Collaborate with Regulatory, Quality, Manufacturing, and Marketing to support product lifecycle.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline required.
• 8-12 years of relevant industry experience, preferably in medical devices or regulated environments.
• Demonstrated experience with medical device quality systems, design controls, and regulatory standards (e.g., FDA, EU MDR).
• Must be authorized to work in the US (sponsorship not available).
• Proficiency with 3D CAD software and standard engineering tools.
• Strong project execution skills including planning and cross-functional coordination.

Nice to have

• Master’s degree or PhD in an engineering or technical discipline.
• Experience leading technical workstreams without direct people management.
• Familiarity with human factors engineering and supplier engagement.
• Project management experience within R&D or new product development.

Culture & Benefits

• Competitive base pay with annual bonus plan eligibility.
• Comprehensive health, dental, and vision insurance programs.
• 401(k) retirement savings plan with safe harbor matching.
• Generous paid time off including 11 holidays and vacation based on service.
• Support for education and adoption assistance programs.
• Inclusive, performance-driven culture focused on innovation and customer needs.