Lead R&D Engineer (Medical Devices)

TL;DR

Lead R&D Engineer (Medical Devices): Leading the identification, design, and commercialization of medical devices with an accent on clinical need exploration, prototype development, and regulatory compliance. Focus on translating clinical requirements into innovative product concepts, managing design verification/validation, and collaborating across cross-functional teams to deliver customer-focused healthcare solutions.

Location: Ballina, Ireland (Onsite)

Company

hirify.global Incorporated 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.
• Research and evaluate new materials, technologies, and processes for product platforms.
• Plan and execute design verification and validation activities in compliance with regulatory standards.
• Develop product specifications and test methods to ensure consistent performance.
• Manage project schedules, technical risk analyses, and documentation for regulatory submissions.

Requirements

• Honours Bachelor’s degree in Mechanical, Biomedical, or Design Engineering.
• 8-12 years of relevant industry experience, preferably in medical devices or regulated environments.
• Proven experience with medical device quality systems, design controls, and regulatory standards (e.g., EU MDR, FDA).
• Proficiency in 3D CAD and standard engineering tools.
• Strong background in product design, prototyping, and verification/validation.
• Ability to lead technical workstreams and coordinate cross-functional teams.

Nice to have

• Master’s degree or PhD in an engineering or technical discipline.
• Experience with human factors engineering in product development.
• Project management experience within an R&D environment.
• Familiarity with supplier engagement and technology scouting.

Culture & Benefits

• Employee-owned company culture focused on innovation and accountability.
• Commitment to a noble purpose of making life more rewarding and dignified for patients.
• Collaborative, inclusive, and performance-driven work environment.
• Opportunities for continuous improvement and professional growth within a global organization.